Search

This study aimed at comparing the anesthetic efficacy of lidocaine injection versus pledgets soaked in lidocaine and epinephrine during radiosurgery of inferior turbinates. The study prospectively enrolled 120 outbound patients, who were randomly assigned to group 1 -anaesthesia with tampon soaked in lidocaine and adrenaline- or group 2 -anesthesia with tampon followed by lidocaine and adrenaline injection. The following parameters were evaluated by a visual analogue scale 1 h after surgery: pain, anxiety, chocking sensation and difficulty swallowing. Nasal obstruction, rhinorrhea, sneezing, headache and inferior turbinate size were evaluated preoperatively (T0), after 1 (T1), 2 (T2) and 3 months (T3) to surgery. The data collected were analyzed by statistic tests. Group 1 showed lesser pain than group 2 during the procedure (p < 0.01); no statistically significant differences were observed for anxiety, chocking sensation and difficulty swallowing. All patients, independently from the belonging group, significantly improved the nasal symptoms comparing T0 and T1 (p < 0.01), T2 (p < 0.01) and T3 (p < 0.01), without statistically significant differences among the groups. Radiofrequency turbinoplasty allowed to all patients to reduce the turbinates hypertrophy. Local anaesthesia with tampon allowed to obtain the same results the injective anaesthesia in term of surgical outcomes; the use of tampon allowed patients did not experience pain. [ABSTRACT FROM AUTHOR]

Background and Aims Carbohydrate sulfotransferase 15 [CHST15] biosynthesizes sulphated matrix glycosaminoglycans and is implicated in intestinal inflammation and fibrosis. Here, we evaluate the efficacy and safety of the double-stranded RNA oligonucleotide GUT-1, a specific blocker of CHST15, as induction therapy in patients with ulcerative colitis [UC]. Methods In this randomized, double-blind, placebo-controlled, phase 2a study, we enrolled endoscopically active UC patients, refractory to conventional therapy, in five hospital centres across Germany. Patients were randomized 1:1:1 using a block randomized technique to receive a single dosing of 25 nM GUT-1, 250 nM GUT-1, or placebo by endoscopic submucosal injections. The primary outcome measure was improvement of endoscopic lesions at weeks 2 or 4. The secondary outcome measures included clinical and histological responses. Safety was assessed in all patients who received treatment. Results Twenty-eight patients were screened, 24 were randomized, and 21 were evaluated. Endoscopic improvement at weeks 2 or 4 was achieved by 71.4% in the GUT-1 250 nM, 0% in the GUT-1 25 nM, and 28.6% in the placebo group. Clinical remission was shown by 57.1% in the GUT-1 250 nM, 0% in the GUT-1 25 nM, and 14.3% in the placebo groups. Histological improvement was shown by 42.9% in the GUT-1 250 nM, 0% in the GUT-1 25 nM, and 0% in the placebo groups. GUT-1 250 nM reduced CHST15 expression significantly and suppressed mucosal inflammation and fibrosis. GUT-1 application was well tolerated. Conclusion Single dosing by submucosal injection of GUT-1 repressed CHST15 mucosal expression and may represent a novel induction therapy by modulating tissue remodelling in UC. [ABSTRACT FROM AUTHOR]

Purpose: Early gastrointestinal tumors can be removed by endoscopic procedures. Endoscopic mucosal dissection (ESD) requires submucosal fluid injection to provide mucosal elevation and prevent intraoperative perforation. However, the clinically applied normal saline mucosal elevation height is low for a short time, which often requires multiple intraoperative injections that increase the inconvenience and procedure time. In addition, recently researched submucosal injection materials (SIM) suffer from complex preparation, poor economy, and poor biocompatibility. Therefore, there is an urgent need for a new type of SIM that can provide long, safe and effective mucosal elevation in support of the endoscopic procedures.Methods: The FS hydrogel is based on polyethylene-polypropylene glycol (F-127) mixed with sodium alginate (SA). The different physicochemical properties of FS hydrogels were characterized through various experiments. Afterward, various biosafety assessments were carried out. Finally, the performance of FS hydrogels was evaluated by in vitro submucosal injection and in vivo swine ESD.Results: The experimental results show that the FS hydrogel is liquid at room temperature, making it easy to inject, and when injected under the mucosa, it undergoes temperature-induced cross-linking, transforming from a liquid to a solid state to provide long-lasting mucosal augmentation. At the same time, the FS hydrogel exhibits controllable gelation, stability, and biocompatibility. The results of in vitro submucosal injections and in vivo ESD procedures showed that FS achieves high mucosal augmentation and provides good submucosal cushioning in the long term.Conclusion: In summary, the F-127/SA hydrogel is simple to synthesize, cost-effective, safe, easy to store, and able to assist ESD well from the perspective of practical clinical problems, indicating that the FS hydrogel can be an ideal potent submucosal injection substitution.

INTRODUCTION: The role of submucosal injection during cold snare polypectomy (CSP) remains uncertain. In this study, we investigated the impact of submucosal saline injection during CSP for colorectal polyps sized 3-9 mm. METHODS: This was a multicenter randomized controlled trial conducted in 6 Chinese centers between July and September 2020 (ChiCTR2000034423). Patients with nonpedunculated colorectal polyps sized 3-9 mm were randomized in a 1:1 ratio to either CSP with submucosal injection (SI-CSP) or conventional CSP (C-CSP). The primary outcome was the incomplete resection rate (IRR). Secondary outcomes included procedure time, intraprocedural bleeding, delayed bleeding, and perforation. RESULTS: One hundred fifty patients with 234 polyps in the SI-CSP group and 150 patients with 216 polyps in the C-CSP group were included in the analysis. The IRR was not decreased in the SI-CSP group compared with that in the C-CSP group (1.7% vs 1.4%, P 51.000). The median procedure time in the SI-CSP group was significantly longer than that in the C-CSP group (108 seconds vs 48 seconds, P < 0.001). The incidences of intraprocedural bleeding and delayed bleeding were not significantly different between the 2 groups (P 5 0.531 and P 5 0.250, respectively). There was no perforation in either group. DISCUSSION: Submucosal saline injection during CSP for colorectal polyps sized 3-9mmdid not decrease the IRR or reduce adverse events but prolonged the procedure time. [ABSTRACT FROM AUTHOR]

To describe an endoscopic technique named 'underwater endoscopic mucosal resection (UEMR) with submucosal injection and marking (UEMR-SIM)' and to evaluate the therapeutic characteristics of superficial non-ampullary duodenal epithelial tumors (SNADETs) < 20 mm vis-a-vis classical EMR (CEMR) and UEMR techniques. This retrospective study included 103 consecutive SNADET patients (103 lesions) who underwent CEMR, UEMR, or UEMR-SIM. The UEMR-SIM procedure included (1) marking and submucosal injection, (2) filling of the duodenal lumen with 0.9% saline, (3) snaring of the lesion, and (4) electrosurgical removal. The procedural outcomes were compared between the UEMR-SIM and other-procedure groups. The en bloc resection rate was significantly higher in the UEMR-SIM group (100%) than in the CEMR group (76.8%) (p = 0.015) but was not statistically different between the UEMR-SIM and UEMR groups (88.0%) (p = 0.236). The R0 resection rate was significantly higher in the UEMR-SIM group (90.9%) than in the UEMR group (48.0%) (p = 0.001) but was not statistically different between the UEMR-SIM and CEMR groups (76.8%) (p = 0.209). Our study indicates that the proposed method, UEMR-SIM for SNADETs, is feasible to achieve a high R0 resection rate and a potentially low local recurrence rate. [ABSTRACT FROM AUTHOR]

Periodontal disease is the most common oral disease seen in dogs, and its routine treatment usually involves dental scaling. Platelet-rich plasma (PRP) therapy may enhance the effectiveness of treatment of periodontal disease, delay the progression of the disease and decrease the time under anesthesia. However, its application in dogs is rarely discussed. The objective of this study was to evaluate the benefits of activated PRP for treatment of periodontal disease in dogs. 43 mL of whole blood was collected from six adult dogs and PRP extracted using the double centrifugation tube method. Subsequently, the PRP was activated using calcium chloride (A-PRP). Significantly elevated concentrations of PDGF-BB (7000.28 pg/mL), TGF-β (378.98 pg/mL), and VEGF (7.14 pg/mL) were detected in the A-PRP. Additionally, three of the dogs with stage 2–3 periodontal disease were enrolled in the clinical trial. Periodontal pocket depth, stage of periodontal disease, gingival index, horizontal bone loss, and alveolar bone density involving the maxillary third and fourth premolar and first molar teeth (107, 108, 109, 207, 208, and 209) were evaluated. Teeth were treated by dental scaling alone (control group) or by dental scaling followed by submucosal injection of 0.1 mL A-PRP per site. After 56 days, significant improvement in periodontal pocket depth, stage of periodontal disease, gingival index, and horizontal bone loss was observed in dogs injected with A-PRP. The high concentrations of growth factors in A-PRP likely contributed to this effect. The use of submucosal injections of A-PRP to treat canine stage 2–3 periodontal disease appears safe and effective for clinical practice. [ABSTRACT FROM AUTHOR]

The use of submucosal injection is crucial for satisfactory submucosal elevation in the early resection of flat polyps originating from the gastrointestinal tract (GIT). Injectable hydrogels derived from natural polypeptides are attractive candidates due to their excellent biocompatibility and easy gelation properties. However, most of the reported hydrogels are not the class of catheter delivery materials due to quick gelation, high inherent viscosity, and injection clogging. This study presents a novel injectable shear-thinning hydrogel platform of small molecules (nonanal) modified gelatin polymer, which offers a promising submucosal injection for effective removal of polyps from GIT. Physicochemical characterizations of hydrogel demonstrate the suitable features as an effective submucosal injection, including shear thinning property, self-assembly, methylene blue dye encapsulation, flow behavior, stability, syringeability (18 G, 21 G, and 24 G needles) and fibrous morphology. Ex vivo investigations of developed submucosal formulation on goat intestines demonstrate the enhanced visibility of cushions and the ability to produce stable, long-lasting cushions of about 8.07 mm up to ∼60 min of submucosal injection. The rapid blood clotting behavior of hydrogel was observed in about 120 s without compromising hemocompatibility with the hemolysis of about 3.77 % only. In vitro biocompatibility of the hydrogel was also verified using the HepG2 and nHDF cells. In vivo study depicts desirable biocompatibility, a non-toxic organ profile, and optimal cushion height in mice models. Studies established the foundation of novel submucosal fluid to improve the therapeutic outcomes of early resection for gastrointestinal polyps. • Gelatin nonanal hydrogel shows excellent physio-mechanical, hemostatic properties, and biocompatibility in vitro and in vivo. • This shear-thinnable gelatin-nonanal hydrogel forms a stable cushion beneath the submucosal layer, ensuring effective support. • Adding methylene blue dye improves the visualization of the gelatin-nonanal hydrogel at the target site for better precision. • This hydrogel aids in endoscopic polypectomy by enabling precise resection and preventing gastrointestinal injury. [ABSTRACT FROM AUTHOR]

Background/Aims: Endoscopic submucosal dissection (ESD) is a curative treatment modality for early gastric neoplasms; however, ESD can be a time-consuming process. To overcome this pitfall, we developed the one-step knife (OSK) approach, which combines an endoscopic knife and injection needle on a single sheath. We aimed to evaluate whether this approach could reduce the ESD procedure time.Methods: This single-blinded randomized multicenter trial at four tertiary hospitals from June 2019 to June 2020 included patients aged 19 to 85 years undergoing ESD. Patients were randomly assigned to two groups (OSK or conventional knife [CK]). The injection time, total procedure time, resected specimen size, submucosal fluid amount, degree of device satisfaction, and adverse events were evaluated and compared between groups.Results: Fifty-one patients were analyzed (OSK: 25 patients and CK: 26 patients). No baseline differences were observed between groups, with the exception of a higher portion of males in the OSK group. The mean injection time was significantly reduced in the OSK group (39.0 seconds) compared to that in the CK group (87.5 seconds, p

Endoscopic submucosal dissection (ESD) is a widely used procedure for the treatment of early and precancerous gastrointestinal lesions and has become the standard treatment. In this procedure, the commonly used materials have a short retention time and a limited lifting capacity, which will prolong the duration of the ESD procedure. Furthermore, these liquids tend to diffuse after ESD surgery, failing to adequately protect the wound. Therefore, we designed and developed injectable hydrogels based on hyaluronic acid. A series of oxidized hyaluronic acid (OHA) and hydrazide hyaluronic acid (AHA) were synthesized, and 16 kinds of injectable hydrogels were fabricated to investigate the effects of molecular structures on the properties of the hydrogels. Among these, the O1A3 hydrogel exhibited a suitable injection performance, gelation time, and mechanical properties, along with good blood and cell compatibility in vitro . Subsequently, in a porcine model of the ESD procedure, the results demonstrated that the O1A3 hydrogel exhibited a good retention time and lifting performance while also significantly reducing the operation time from 1-2 h to ∼10 min. Furthermore, the adhesive property of the O1A3 hydrogel on small bleeding spots and wounds could be observed, which was beneficial in protecting the wound from the complex environment of the gastrointestinal tract. The present work of injectable hyaluronic acid-based hydrogels could be promising to improve the efficiency of ESD surgery.

Objective: To establish the efficacy of mean pain control after submucosal tramadol injection compared to placebo after surgical removal of the impacted third molar. Study Design: Quasi-experimental study. Place and Duration of Study: Department of Maxillofacial Surgery, Armed Forces Institute of Dentistry, Rawalpindi Pakistan, from Feb to Aug 2018. Methodology: All the patients had symmetrical bilateral impactions of the third molar on an orthopantomogram. The surgical site was randomly selected, and those in Group-T received Tramadol injection submucosally adjacent to the extraction socket immediately after the first tooth extraction, and Group-P received Saline. After the second extraction, Group-T received a Saline injection, and Group-P received Tramadol in the same manner. Patients were followed 24 hours post-operative for pain grading at 2, 4 and 24 hours, frequency and concentration of analgesic intake and duration of anaesthesia. Results: Mean age of participants was 23.80±2.80 years. Means of pain intensity of Group without Tramadol after 2, 4 and 24 hours of extraction are 8.40±0.90, 6.30±0.40 and 2.10 ± 0.40, respectively, and those with Tramadol are 5.90±0.50, 4.50±0.30 and 1.60±0.40 respectively. Conclusion: Our study concluded that Tramadol was more effective in providing analgesia after third molar surgery than local anaesthesia alone. [ABSTRACT FROM AUTHOR]

Targeting the release of drugs in specific sites of the upper GI tract would meet local therapeutic goals, improve the bioavailability of specific drugs and help overcoming compliance-related limitations, especially in chronic illnesses of great social/economic impact and involving polytherapies (e.g. Parkinson's and Alzeimer's disease, tubercolosis, malaria, HIV, HCV). It has been traditionally pursued using gastroretentive (GR) systems, i.e. low-density, high-density, magnetic, adhesive and expandable devices. More recently, the interest towards oral administration of biologics has prompted the development of novel drug delivery systems (DDSs) provided with needles and able to inject different formulations in the mucosa of the upper GI tract and particularly of esophagus, stomach or small intestine. Besides comprehensive literature analysis, DDSs identified as smart devices in view of their high degree of complexity in terms of design, working mechanism, materials employed and manufacturing steps were discussed making use of graphic tools. [Display omitted] [ABSTRACT FROM AUTHOR]

Background/Aims Cold snare polypectomy (CSP) is an effective method of polyp removal for small colorectal polyps. However, the effect of submucosal injection in cold snare endoscopic mucosal resection (CS-EMR) for small polyps is unclear. Therefore, this study aimed to evaluate the effect of submucosal injection in CS-EMR for small polyps. Methods Between 2018 and 2019, 100 consecutive small colorectal polyps (5–10 mm) were identified in 58 patients. The first 50 consecutive polyps were removed by CS-EMR, and the remaining 50 were removed by CSP. Demographic data, clinical data, endoscopic findings, procedure times, complication rates, and pathology data were collected. Results No difference in the complete resection rate was observed between the CS-EMR and CSP groups. A total of 9 polyps showed post-polypectomy bleeding (7 had immediate bleeding, 1 had delayed bleeding, and 1 had both immediate and delayed bleeding). No difference in the bleeding rate was observed between the two groups. In multivariate analysis, warfarin (odds ratio [OR], 42.334; 95% confidence interval [CI], 1.006–1,781.758) and direct-acting oral anticoagulants (OR, 35.244; 95% CI, 3.853–322.397) showed a significantly increased risk of bleeding. Conclusions The effect of submucosal injection in CSP was not significant for small colorectal polyps.

Aim: To establish the effects of submucosal tramadol, dexamethasone and articaine on the success of inferior alveolar nerve blocks (IANB) during root canal treatment of mandibular molars with symptomatic irreversible pulpitis (SIP). Methodology: In this randomized double‐blind, controlled clinical trial, 120 patients with the diagnosis of SIP in their mandibular first or second molars were included and randomly divided into four groups (n = 30). The control group received normal saline and three experimental groups received a single dose of dexamethasone (8 mg/2 mL), or tramadol (100 mg/2 mL) or articaine (4% / 2 mL). The pre‐operative pain levels of the patients were measured with the Heft‐Parker visual analogue scale (HP VAS). All patients received standard IANB of 4% articaine with 1:200000 epinephrine. Following the observation of lip numbness, submucosal injections were administered into the mucobuccal fold adjacent to the mandibular molars. After 15 min, standard root canal treatment was initiated, and the pain intensity levels recorded from the access cavity preparation to pulp extirpation were measured with HP VAS. The duration of the anaesthesia was also evaluated. The experimental groups were compared using one‐way ANOVA or Kruskal–Wallis H‐test. The groups that were significantly different were compared pairwise using the Tukey Multiple Comparison test. The Chi‐square test was used to compare the categorical variables. Results: The submucosal administration of articaine significantly increased the success rate to 63% in comparison with the control group that received submucosal saline (p <.05). The success rate of pulpal anaesthesia was 37% in the control group, 57% in the tramadol group and 47% in the dexamethasone group, with no significant difference in the success rate among these groups. In the dexamethasone group, the duration of the anaesthetic effect of IANB was significantly longer than those in the other groups (p <.001). Conclusions: In patients with SIP, pre‐operative submucosal administration of articaine increased the success rate of IANB, while administration of dexamethasone increased the duration of anaesthesia. These agents can be used in cases where effective anaesthesia cannot be obtained during root canal treatments. [ABSTRACT FROM AUTHOR]

Background Thermal damage to the muscle layer during mucosal application of argon plasma coagulation (APC) may be avoided by creating a fluid cushion within the submucosal layer, but the minimum injection volume needed or the ideal injection fluid are yet to be established. We conducted a systematic ex vivo study with this aim. Methods All experiments were performed in an ex vivo porcine gastrointestinal tract model. Five different fluids (saline, Glyceol, Gelafundin, Voluven, and Eleview) of different volumes were injected into the submucosa of different parts of the gastrointestinal tract. APC was applied to the mucosa at different power settings. Immediately after APC treatment, the temperature was measured through a thermocouple placed inside the fluid cushion, just on top of the muscle layer. The minimum volume of fluid needed to protect the muscle layer from thermal damage was determined. Results There was no difference in the temperature measured among the different injection fluids at the surface of the muscle, in all the locations, at equal injection volumes and power settings. The minimum amounts of fluid needed to protect the muscle layer were 2 and 3 mL for power settings of 30-90 W and 90-120 W, respectively. Conclusions Normal saline and 4 commercially available submucosal injection fluids possess similar thermal protective effects. To reduce the likelihood of thermal damage to deeper layers when APC is applied, a minimum injection volume of 3 mL is recommended if less than 90 W power will be utilized over 3 sec. [ABSTRACT FROM AUTHOR]

Endoscopic retrograde cholangiopancreatography (ERCP) of the intradiverticular papilla with its invisible orifice remains challenging. Several techniques have been introduced to evert the papillary opening to facilitate cannulation. A 79-year-old woman with bile duct stones underwent ERCP, which revealed that the papilla was located inside a large diverticulum and tended to rotate inward with a trial of papillary cannulation. Submucosal papillary injection of 3 cc of normal saline was performed at 3 and 9 o’clock. Eversion and fixation of a papilla in the diverticulum with this technique allowed selective cannulation of the biliary tree. Stones were retrieved after endoscopic papillary balloon dilation without complications. She had an uneventful post-procedural course. Our findings suggest that submucosal saline injection technique is safe and effective for selective cannulation and can be recommended when cannulation is very difficult because of an intradiverticular papilla.

Background: Submucosal injection of lifting solution is often performed to facilitate endoscopic mucosal resection or endoscopic submucosal dissection. ORISETM gel is a synthetic solution recently approved by the US Food and Drug Administration (FDA) in 2018 for use as submucosal lifting solution for endoscopic resection procedures and has gained popularity for its convenient pre-filled syringe. However, here the present two cases show that ORISETM gel induces marked foreign body giant cell granulomatous reaction in the submucosa and muscularis propria following endoscopic resection. Methods and results: A 73-year-old female underwent laparoscopic right colectomy after her initial endoscopic polypectomy of a hyperplastic polyp, and a 78-year-old male had partial gastrectomy following endoscopic mucosal resection of an invasive adenocarcinoma. Both patients had submucosal injection of ORISETM gel during endoscopic procedures, and the surgical resection specimens showed ORISETM gel deposition and extensive foreign body giant cell granulomatous reaction in the submucosa and muscularis propria. Conclusion: These cases raise the awareness that ORISETM gel stimulates extensive foreign body reaction at the injection site, and the further consequence is still unclear. [ABSTRACT FROM AUTHOR]

Objective: A submucosal injection is usually required to improve the efficacy and safety of endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR). This study aimed to evaluate the performance of 3.3% sodium carboxymethyl starch (Na‐CMS) solution, a novel submucosal injection solution, for ESD and EMR. Methods: Na‐CMS, normal saline (NS) and two commercially available agents (sigMAVisc and Eleview) were injected into the esophageal submucosa of randomly grouped pigs. The level of submucosal elevation was examined. Subsequently, ESD or EMR procedures using 3.3% Na‐CMS or NS as submucosal injections were performed in the gastrointestinal tract of the pigs. Results: Submucosal elevation was significantly higher and more sustained in the 3.3% Na‐CMS group than in the controls (P < 0.05). The volume required for ESD or EMR was significantly lower in the 3.3% Na‐CMS group than in the NS group (ESD: 12.21 ± 4.09 mL vs 28.25 ± 8.02 mL, P < 0.001; EMR: 3.99 ± 1.98 mL vs 7.15 ± 3.67 mL, P = 0.001). The ESD resection time was significantly shorter in the 3.3% Na‐CMS group than in the NS group (16.58 ± 7.30 min vs 25.29 ± 11.89 min, P = 0.004). Hemorrhage after ESD in the 3.3% Na‐CMS group was less severe than that in the NS group (P = 0.006). Conclusion: 3.3% Na‐CMS is an effective, safe and low‐cost submucosal injection solution and holds promise as preferable agent for submucosal injection in ESD and EMR procedures. [ABSTRACT FROM AUTHOR]

Purpose: Early gastrointestinal tumors can be removed by endoscopic procedures. Endoscopic mucosal dissection (ESD) requires submucosal fluid injection to provide mucosal elevation and prevent intraoperative perforation. However, the clinically applied normal saline mucosal elevation height is low for a short time, which often requires multiple intraoperative injections that increase the inconvenience and procedure time. In addition, recently researched submucosal injection materials (SIM) suffer from complex preparation, poor economy, and poor biocompatibility. Therefore, there is an urgent need for a new type of SIM that can provide long, safe and effective mucosal elevation in support of the endoscopic procedures. Methods: The FS hydrogel is based on polyethylene-polypropylene glycol (F-127) mixed with sodium alginate (SA). The different physicochemical properties of FS hydrogels were characterized through various experiments. Afterward, various biosafety assessments were carried out. Finally, the performance of FS hydrogels was evaluated by in vitro submucosal injection and in vivo swine ESD. Results: The experimental results show that the FS hydrogel is liquid at room temperature, making it easy to inject, and when injected under the mucosa, it undergoes temperature-induced cross-linking, transforming from a liquid to a solid state to provide long-lasting mucosal augmentation. At the same time, the FS hydrogel exhibits controllable gelation, stability, and biocompatibility. The results of in vitro submucosal injections and in vivo ESD procedures showed that FS achieves high mucosal augmentation and provides good submucosal cushioning in the long term. Conclusion: In summary, the F-127/SA hydrogel is simple to synthesize, cost-effective, safe, easy to store, and able to assist ESD well from the perspective of practical clinical problems, indicating that the FS hydrogel can be an ideal potent submucosal injection substitution., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Xu, Yang, Yi, Tan, Li, Feng, Rao, Zhou, Hu and Zhan.)

The aim of the present study is to compare the efficacy of additional 100 mg/2 ml tramadol and 40 mg/2 ml lidocaine applications on the anesthetic success of inferior alveolar nerve block (IANB) in mandibular molars with symptomatic irreversible pulpitis (MM-SIP). One hundred and five patients diagnosed with symptomatic pulpitis in the lower first or second molars were included in the study. Patients were randomly divided into three groups (n = 35) composed of control and two experimental groups administered submucosal tramadol and lidocaine. Preoperative pain levels of the patients were measured with Heft-Parker visual analog scale (HP VAS). Following, standard IANB with 2% lidocaine 1: 80,000 was administrated to all groups. After observation of lip numbness, 2 ml of saline in the control group, 100 mg/2 ml tramadol in tramadol group and 40 mg/2 ml (2%, 1: 80,000) lidocaine in lidocaine group were administered submucosally. After 15 min, standard endodontic treatment was initiated and the pain levels measured from access cavity preparation to pulp extirpation were measured with HP VAS. The success rate of pulpal anesthesia was 28.5% in the control group, 45.7% in the submucosal lidocaine group and 48.6% in the tramadol group. There was no statistically significant difference in the success rate between the groups. Additional submucosal administration of 100 mg tramadol did not significantly increase the success of IANB applied with a combination of 2% lidocaine 1:80,000 and epinephrine in MM-SIP compared to control group. [ABSTRACT FROM AUTHOR]

The objective of this study was to compare the effect of intraosseous dexamethasone injection and submucosal dexamethasone injection on postoperative sequelae after mandibular third molar surgery. This was a randomized, triple-blind, split-mouth clinical trial. Fifty-four mandibular third molars (27 patients) were subdivided according to the side (right and left); intraosseous injection of dexamethasone (4 mg) was randomly assigned to one side and submucosal injection to the other. All surgeries were performed by one surgeon. Postoperative pain was evaluated by visual analogue scale score immediately after surgery and on postoperative days 1, 3, and 7. Postoperative swelling (determined using two linear measurements) and mouth opening (determined by measurement of the inter-incisal distance) were assessed on postoperative days 3 and 7. The number of analgesics consumed was recorded. No significant difference in pain or swelling was found between the two injection techniques. However, there was significant difference in trismus on postoperative day 3, with submucosal injection showing a better outcome (P < 0.001). Both techniques of dexamethasone injection were effective in controlling pain and swelling after mandibular third molar surgery, but submucosal injection was superior for the control of trismus. [ABSTRACT FROM AUTHOR]

Background: Surgical management of gastric gastrointestinal stromal tumors (GISTs) has evolved towards minimal invasiveness. Laparoscopic wedge resection and laparoscopic and endoscopic cooperative surgery had been considered as standard surgical treatments for gastric GISTs > 2 cm. However, stomach deformation and the full-thickness gastric defect caused by these procedures may increase the risk of morbidity. To address these problems, we developed a novel technique, third space robotic and endoscopic cooperative surgery (TS-RECS), which could dissect the tumor entirely while preserving the intact mucosal layer. Here we performed a prospective evaluation of the feasibility and safety of TS-RECS.Methods: Patients with gastric GISTs were recruited between April 2018 and April 2019. During the operation, the gastric GIST was located by endoscopic view firstly and the submucosal injection was performed. The tumor was then dissected through robotic surgery. Clinicopathological characteristics, operative data, adverse events, and follow-ups were prospectively collected and analyzed.Results: A total of 20 patients with gastric GISTs received TS-RECS. The mean tumor size was 33.0 ± 7.3 mm. R0 resection was achieved in all patients with a median operation time of 115 min and a median blood loss of 20 ml. The integrity of mucosal layer was maintained in 95% (19/20) of the patients. All patients started oral diet on postoperative day 1 or 2, staying in the hospital for a median of 6 days after surgery. There were no major adverse events. Local or distant recurrences were not observed during a median follow-up period of 10 months.Conclusions: Our study suggests that TS-RECS appears to be a feasible and safe technique which could be an alternative method for resecting gastric GISTs > 2 cm.Clinical Trials: ClinicalTrials.gov NCT03804762. [ABSTRACT FROM AUTHOR]

Background: There are many studies on submucosal injection materials, but their clinical use is restricted for various reasons. The objective of this study was to compare the feasibility and safety of injected EndoClot®SIS polysaccharide as a submucosal injection material (SFC) in ESD in the pig stomach to that of injected sigMAVisc™ or Eleview™.Methods: Four pig stomachs were used for the ex vivo study. Eighteen pigs were used for the in vivo study. In the ex vivo study, four injections were made in the gastric submucosa to induce submucosal uplift and extend its duration. Tissue change was observed. The in vivo study was performed in 2 steps. First, 3 injections were made in the esophageal mucosa to induce submucosal uplift and extend its duration. Histological change was observed. Second, ESD was performed in the stomach by injecting EndoClot®SIS polysaccharide, sigMAVisc™, or Eleview™ (each, n = 6) as an SFC. The effects of these agents on wound healing were examined. We evaluated the efficacy and safety of endoscopic surgery after EndoClot®SIS polysaccharide injection.Results: EndoClot®SIS polysaccharide produced a longer-lasting elevation with clearer margins than was achieved by sigMAVisc™, Eleview™, or 0.9% NaCl and thereby enabled precise ESD without complications, such as bleeding and perforation. No obvious histopathological damage was observed at the injection site on endoscopy and histology.Conclusion: Submucosally injected EndoClot®SIS polysaccharide increased the effective separation of the mucosa and submucosa and reduced surgical complications. Hence, EndoClot®SIS polysaccharide injection is a safe and effective submucosal injection material. [ABSTRACT FROM AUTHOR]

Background and Aim: The study of electrical and rheological properties of solutions to carry out endoscopic resection procedures could determinate the best candidate. An ex vivo study with porcine stomachs was conducted to analyze electrical resistivity (R) and rheological properties (temperature, viscosity, height and lasting of the cushion) of different substances used in these techniques. Methods: Tested solutions were: 0.9% saline (S), platelet‐rich plasma (PRP), Gliceol (GC), hyaluronic acid 2% (HA), Pluronic‐F127 20% (PL), saline with 10% glucose (GS), Gelaspan (GP), Covergel‐BiBio (TB) and PRP with TB (PRP+TB). Measurements of electrical and rheological properties were done at 0, 15, 30, 45 and 60 min after submucosal injection. Results: Solutions showed a wide variability of transepithelial R after submucosal injection. Substances able to maintain the highest R 60 min postinjection were TB (7 × 104 Ω), HA (7 × 104 Ω) and PL (7 × 104 Ω). Protective solutions against deep thermal injury (Tª lower than 60°C) were PL (47.6°C), TB (55°C) and HA (56.63°C). Shortest time to carry out resections were observed with GC (17.66″), PRP (20.3″) and GS (23.45″). Solutions with less cushion decrease (<25%) after 60 min were TB (11.74%), PL (18.63%) and PRP (22.12%). Conclusions: Covergel‐BiBio, PL and HA were the best solutions with long‐term protective effects (transepithelial R, lower thermal injury and less cushion decrease). Solutions with quicker resection time were GC, PRP and GS. [ABSTRACT FROM AUTHOR]

Effect of submucosal injection of normal saline and glycerol fructose on endoscopic polypectomy in patients with colorectal polyps was investigated. A total of 275 patients with colorectal polyps were enrolled in this study and underwent endoscopic gastrointestinal polypectomy in Qingdao Chengyang People's Hospital from March 2013 to December 2016. Among them, 150 patients who underwent submucosal injection of glycerol fructose were set as the experimental group, and 125 patients who underwent submucosal injection of normal saline were set as the control group. The surgery conditions, complications and recurrence rates were compared between the two groups. The time of processing polyps and the total surgery time in the experimental group were shorter than those in the control group (P<0.05). The number of repeated injections in the experimental group was less than that in the control group, and the difference was statistically significant (P<0.05). The amount of fluid and propofol injected in patients of the experimental group was significantly lower than that of the control group, and the difference was statistically significant (P<0.05). The en bloc resection rate (EBRR) and complete resection rate (CRR) in the experimental group were 68.0 and 48.0%, respectively. EBRR and CRR in the control group were 49.6 and 27.2%, respectively. EBRR and CRR in the experimental group were significantly higher than those in the control group (P<0.05). After follow-up of the patients for 3 months, there was no significant difference in the recurrence rate between the two groups (P>0.05). The results indicated that endoscopic colorectal polypectomy with glycerol fructose as a submucosal injection can shorten the time of surgery, reduce the number of repeated injections, reduce the amount of fluid and propofol, and also improve EBRR and CRR. [ABSTRACT FROM AUTHOR]

Background and Aims: Mucosal lifting and its persistence are critical for maintaining the operational space and preventing perforation in endoscopic operation. Although numerous agents have been investigated, optimization is still required for improving their clinical performance. In the present study, we proposed a novel concept of thermoresponsive aerification and tissue vacuolization for submucosal injection. Methods: Lifting performance and operational condition were first evaluated in porcine stomachs in vitro and rabbits in vivo. Dodecafluoropentane (DDFP) injection dosage, lifting persistency and operational assistance were quantitatively recorded. Gross and histological pathology were also analyzed to identify DDFP acute toxicity and long‐term safety. The endoscopic submucosal dissection (ESD) procedure with DDFP was carried out on pigs in vivo to confirm its operational feasibility, efficacy, and safety. Results: Dodecafluoropentane aerification could achieve better mucosal lift with lower dosage (1% of normal saline dosage). Thermoresponsive DDFP aerification could provide continuous replenishment and longer persistence. Meanwhile, its tissue vacuolization effect significantly facilitated submucosal tissue dissection in in vitro study. Similar performance was verified in vivo. The particular vacuole‐like submucosal structure was seen after DDFP onset, which also promoted reepithelization and wound healing. No tissue damage, gas embolism, biotoxicity, and physicochemical risk were observed. Conclusion: Bioinert DDFP was feasible, efficient, and safe as the novel submucosal lifting candidate. [ABSTRACT FROM AUTHOR]

Diclofenac sodium is a widely used nonsteroidal anti-inflammatory drug (NSAID) for relief of inflammatory pain. A recent formulation combines this drug with hydroxypropyl-β-cyclodextrin (HPβCD) to improve its solubility and to enable subcutaneous administration. Previous studies confirmed the efficacy of this combination. This study's aim was to evaluate the efficacy, safety, and local tolerability of diclofenac HPβCD administered as a local submucosal injection prior to lower third molar surgery. We conducted a prospective, randomized, double-blind, placebo-controlled, parallel-group phase II single-center study. Seventy-five patients requiring mandibular third molar surgery were randomized into 1 of 5 groups: 5 mg/1 mL diclofenac HPβCD, 12.5 mg/1 mL diclofenac HPβCD, 25 mg/1 mL diclofenac HPβCD, 50 mg/1 mL diclofenac HPβCD, or 1 mL placebo. The respective study drug was injected into the mucosal tissue surrounding the surgical site prior to surgery following achievement of local anesthesia. The primary outcome measure was the area under the curve (AUC) of cumulative pain scores from end of surgery to 6 h postsurgery. This demonstrated a global treatment effect between the active groups and placebo, hence confirming the study drug's efficacy ( P = 0.0126). Secondary outcome measures included the time until onset of pain and the time until patients required rescue medication, both showing statistical significance of the study drug compared to placebo ( P < 0.0161 and P < 0.0001, respectively). The time until rescue medication ranged between 7.8 h (for 25 mg/1 mL diclofenac HPβCD) and 16 h (for 50 mg/1 mL diclofenac HPβCD). Interestingly, the 5-mg/1-mL solution appeared superior to the 12.5-mg/1-mL and 25-mg/1-mL solutions (time until rescue medication = 12.44 h). A total of 14% of patients experienced minor adverse drug reactions (ADRs), of which 2 cases demonstrated flap necrosis. These resolved without further intervention. The study results overall indicate efficacy, safety, and relative tolerability of diclofenac HPβCD used locally as a submucosal injection prior to third molar surgery (ClinicalTrials.gov NCT01706588). [ABSTRACT FROM AUTHOR]

Background/aims: Submucosal injection with indigo carmine mixed solution can improve the delineation of colorectal neoplasia during endoscopic mucosal resection (EMR). Thus, the aim of this study was to evaluate the efficacy of submucosal injection with indigo carmine mixed solution during EMR of colorectal neoplasia.Methods: This was a prospective, randomized, controlled study of a total of 212 neoplastic colon polyps (5-20 mm) subjected to EMR in a single tertiary university hospital. The patients were randomized into two groups according to whether or not indigo carmine mixed solution was used, and the complete resection rate (CRR) after EMR was evaluated.Results: A total of 212 neoplastic polyps (normal saline group, 115; indigo carmine group, 97) were successfully removed by EMR. There was no significant difference in the CRR (92.8 vs. 89.6%, p = 0.414) or macroscopic delineation (86.0 vs. 93.8%, p = 0.118) between the two groups. In a separate analysis of sessile serrated adenomas/polyps (SSAs/Ps), macroscopic delineation was better in the indigo carmine group than the normal saline group (87.5 vs. 53.8%), albeit not significantly (p = 0.103). In univariate analyses, the CRR was significantly related to polyp location, polyp morphology, macroscopic delineation, and pathologic findings. In a multiple logistic regression analysis, macroscopic delineation (odds ratio (OR), 7.616, p = 0.001) and polyp pathology (OR, 8.621; p < 0.001) were significantly associated with the CRR.Conclusions: Submucosal injection with indigo carmine mixed solution did not improve the CRR or macroscopic delineation of EMR of colorectal neoplasias. [ABSTRACT FROM AUTHOR]