Search

Data on the clinical efficacy of EUS-guided ablation using the HybridTherm-Probe (EUS-HTP) in locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) are lacking. The aim of the study was to assess the impact of EUS-HTP added to chemotherapy (CT) on overall survival (OS) and progression-free survival (PFS) of LA-PDAC patients with local disease progression (DP) after first-line therapy, compared to CT alone in controls.LA-PDAC cases, prospectively treated by EUS-HTP, were retrospectively compared to matched controls (1:2) receiving standard treatment. Study endpoints were the OS and PFS from local DP after first-line therapy, compared through log-rank test calculating hazard ratios and differences in restricted mean OS/PFS time (RMOST/RMPFST) within prespecified time points (4, 6, and 12 months).Thirteen cases and 26 controls were included. Clinical, tumor, and therapy features before and after first-line therapy were case-control balanced. The median OS and PFS were not significantly improved in cases over controls (months: 7 vs. 5 and 5 vs. 3, respectively). At 4 and 6 months, the RMPFST difference was in favor of cases (P = 0.0001 and P = 0.003, respectively). In cases and controls not candidate to further CT (N = 5 and N = 9), the median OS and PFS were not significantly improved in cases over controls (months: 6 vs. 3 and 4 vs. 2, respectively), but the RMPFST difference was in favor of cases at 4 months (P = 0.002).In locally progressive PDAC patients experiencing failure of first-line therapy, EUS-HTP achieves a significantly better RMPFST up to 6 months compared to standard treatment, although without a significant impact on OS.

(1) Background: Cervical intraepithelial neoplasia (CIN) of long-term persistence or associated with individual treatment indications often requires highly invasive treatments. These are associated with risks of bleeding, infertility, and pregnancy complications. For low- and middle-income countries (LMICs), standard treatment procedures are difficult to implement and manage. We characterized the application of the highly energized gas “noninvasive physical plasma” (NIPP) for tissue devitalization and the treatment of CIN. (2) Methods: We report the establishment of a promising tissue devitalization procedure by NIPP application. The procedure was characterized at the in vitro, ex vivo and in vivo levels. We performed the first prospective, single-armed phase-IIb trial in 20 CIN1/2 patients (NCT03218436). (3) Results: NIPP-treated cervical cancer cells used as dysplastic in vitro model exhibited significant cell growth retardation due to DNA damage, cell cycle arrest and apoptosis. Ex vivo and in vivo tissue assessments showed a highly noninvasive and tissue-preserving treatment procedure which induces transmucosal tissue devitalization. Twenty participants were treated with NIPP and attended a 24-week follow-up. Treatment success was achieved in 19 (95%) participants without postinterventional complications other than mild to moderate discomfort during application. (4) Conclusions: The results from this study preliminarily suggest that NIPP could be used for an effective and tissue-preserving treatment for CIN without the disadvantages of standard treatments. However, randomized controlled trials must confirm the efficacy and noninferiority of NIPP compared to standard treatments.

(1) Background: Cervical intraepithelial neoplasia (CIN) of long-term persistence or associated with individual treatment indications often requires highly invasive treatments. These are associated with risks of bleeding, infertility, and pregnancy complications. For low- and middle-income countries (LMICs), standard treatment procedures are difficult to implement and manage. We characterized the application of the highly energized gas "noninvasive physical plasma" (NIPP) for tissue devitalization and the treatment of CIN. (2) Methods: We report the establishment of a promising tissue devitalization procedure by NIPP application. The procedure was characterized at the in vitro, ex vivo and in vivo levels. We performed the first prospective, single-armed phase-IIb trial in 20 CIN1/2 patients (NCT03218436). (3) Results: NIPP-treated cervical cancer cells used as dysplastic in vitro model exhibited significant cell growth retardation due to DNA damage, cell cycle arrest and apoptosis. Ex vivo and in vivo tissue assessments showed a highly noninvasive and tissue-preserving treatment procedure which induces transmucosal tissue devitalization. Twenty participants were treated with NIPP and attended a 24-week follow-up. Treatment success was achieved in 19 (95%) participants without postinterventional complications other than mild to moderate discomfort during application. (4) Conclusions: The results from this study preliminarily suggest that NIPP could be used for an effective and tissue-preserving treatment for CIN without the disadvantages of standard treatments. However, randomized controlled trials must confirm the efficacy and noninferiority of NIPP compared to standard treatments.

Purpose Endometriosis is a benign, but potentially serious gynaecological condition in terms of abdominal pain and impaired fertility. Laparoscopic excision techniques are considered the therapeutic standard. HybridAPC is presented as a novel technique for the non-contact thermal ablation of peritoneal endometriosis with simultaneous protection of the underlying thermosensitive structures by creating a needle-free elevated fluid cushion which enables a safer exposure and distance, as well as potentially improved peritoneal conditioning prior to APC. Methods In this prospective randomized clinical trial, 39 patients with 132 superficial endometriotic lesions in total were treated with HybridAPC or sharp excision in an initial laparoscopic procedure according to randomization. In a second-look laparoscopy, adhesion formation was rated macroscopically. Histologic samples were taken from previously treated areas for evaluation of eradication rate. Results The eradication rate was not significantly different between HybridAPC treatment and sharp excision (65 vs. 81%, p = .55). Adhesions formed in 5% of HybridAPC-treated lesions and in 10% after sharp excision (p = .49). HybridAPC treatment was significantly faster than sharp excision (69 vs. 106 s, p Conclusion This clinical trial demonstrates the feasibility of this novel surgical technique with a promising impact on adhesion prevention. Compared to sharp excision, HybridAPC is likely to be a safe, tissue-preserving, and fast method for the treatment of peritoneal endometriosis.

Background and study aims Indeterminate biliary strictures represent a major challenge in clinical diagnostics. Diagnostic yield of radiological, endoscopic imaging and histopathological diagnosis is insufficient. The cryobiopsy technique is a new method for tissue extraction already used in different clinical settings. The aim of this ex vivo clinical study was to investigate feasibility and tissue quality of cryobiopsy in the bile duct. Patients and methods We included 14 patients who underwent pancreaticoduodenectomy. Bile duct samples were taken with either a new prototype cryoprobe or one of two forceps types. Results were analyzed for general feasibility, specimen size, histological assessability as well as representativity of retrieved tissue. Results Feasibility of cholangioscopic forceps was poor compared to gastric biopsy forceps or cryobiopsy. Significantly larger tissue samples were obtained with cryobiopsy (5.6 ± 4.5 mm2) compared to gastric biopsy forceps (3.3 ± 5.1 mm2, P = 0.006). Furthermore, cryobiopsy was superior in histological assessment quality (P = 0.02) and concerning representativity (P = 0.03). Conclusions Cryobiopsy in the bile duct is feasible and the quality of the obtained tissue is high. Further investigation of bile duct cryobiopsy in vivo is warranted.

As the pig model has similar gastrointestinal anatomy and physiology to humans, we used pigs to create a gastric mucosal devitalization (GMD) model in preparation for clinical translation of this technique as an endoscopic bariatric therapy (EBT). The aims of this study were to determine the ablation parameters and technique for a successful, safe, and feasible large surface area GMD that produces weight loss.We performed GMD using argon plasma coagulation (APC) in 3 phases. Phase 1 assessed the ablation energy required to accomplish selective mucosal ablation using ex vivo pig stomachs (n = 2). Phase 2 assessed the optimal percentage of mucosal surface area to be treated and was performed on 10 pigs. Phase 3 assessed feasibility, efficacy, and safety with 8 pigs randomized into GMD (n = 4) or sham (SH, n = 4) and survived for 1 month. Body weights (GMD, n = 4, SH, n = 4) were measured daily in phase 3 for 1 month, and relative body weights were calculated and analyzed using one-tailed Student's t-test. Percent body fat was compared between GMD and SH at baseline and 1 month post-GMD.Phase 1 identified the optimal ablation parameters (120 W) that were then used in phase 2. Phase 2 revealed a trend that was suggestive that the optimal percent surface area to ablate was similar to that which is removed at laparoscopic sleeve gastrectomy. In phase 3, GMD was performed over 70% surface area of the greater curvature of the stomach in four pigs. GMD pigs had significantly lower relative body weight increase compared to SH at 1 month (1.375 ± 0.085 vs 1.575 ± 0.047, p = 0.0435). MRI showed a significantly lower body fat mass at 1 month in GMD pigs (5.9 ± 0.4% vs 12.7 ± 2.3%, p = 0.026) compared to SH.GMD resulted in decreased weight gain in the GMD group as evidenced by a lower relative body weight at 1 month. GMD in an animal model appears to show promise as a potential weight loss therapy.

Die Elektrochirurgie wurde vor nahezu 100 Jahren gleich zweimal erfunden: von einer Firma in Tübingen und von einem Wissenschaftler in den USA. Heutzutage zählt ein Elektrochirurgiegerät zur Grundausstattung eines jeden Operationssaals. Mediziner können damit gleichzeitig schneiden und Blutungen stillen, Tumore zerstören oder Gefäße versiegeln. Gerade für minimalinvasive Techniken hat die Elektrochirurgie die Voraussetzungen für wegweisende neue Therapiemöglichkeiten geschaffen.

Background: Cryoextraction is a procedure used for the recanalization of obstructed airways caused by visible exophytic endobronchial tumor. Biopsy samples obtained by this technique have been shown to be useful for histological assessment. Objectives: The aim of the present animal study was to systematically evaluate biopsy size, histological quality and bleeding risk after cryobiopsy with new, flexible cryoprobes in comparison with forceps biopsy, serving as the gold standard. Methods: Biopsies were obtained from anesthetized pigs with the flexible bronchoscopy technique, and evaluated histologically with respect to their size and quality. Bleeding frequency, bleeding duration and histological changes in the biopsy bed were also recorded. Results: Cryobiopsies were significantly larger than forceps biopsies. The size of cryobiopsies was dependent on the freezing time. The histological quality of the cryobiopsy specimenswas not impaired by the freezing process, whereas forceps biopsies showed typical crush artifacts. Despite the larger defects left in the tracheobronchial system after cryobiopsy, bleeding frequency and duration were not higher compared to forceps biopsy. Conclusions: Since cryobiopsy sampling is not associated with a higher bleeding risk compared with forceps biopsy, this new biopsy technique offers – in addition to a good specimen quality – a safe and valuable tool with the potential of improving the outcome of diagnostic endoscopy.

Complete surgical removal of cancer tissue with effective preservation of healthy tissue is one of the most important challenges in modern oncology. We present a method for real-time, in situ differentiation of tissue based on optical emission spectroscopy (OES) performed during electrosurgery not requiring any biomarkers, additional light sources or other excitation processes. The analysis of the optical emission spectra, enables the differentiation of healthy and tumorous tissue. By using multi-class support vector machine (SVM) algorithms, distinguishing between tumor types also seems to be possible. Due to its fast reaction time (0.05s) the method can be used for real-time navigation helping the surgeon achieve complete resection. The system’s easy realization has been proven by successful integration in a commercial electro surgical unit (ESU). In a first step the method was verified by using ex vivo tissue samples. The histological analysis confirmed, 95% of correctly classified tissue types.

Argon plasma coagulation (APC) is a monopolar, noncontact, thermal procedure that is widely used in therapeutic endoscopy. Systematic investigations of the tissue damage ex vivo and in vivo with the new, second-generation APC modes are lacking.The aim of this study is to compare the tissue effects of the pulsed effect 2 and precise APC modes.Ex vivo and in vivo animal model.This study involved 3 explanted porcine esophagi and 8 pigs under general anesthesia.APC application on 3 explanted esophagi and during esophagoscopy.The tissue effect was subjected to histological and statistical investigation.In vivo, a well known type of superficial tissue damage (type A) of the tunica mucosa and a new injury pattern (type B) limited to the tunica muscularis, were found. Ex vivo, only type A injuries were seen. Thermal injury of the tunica muscularis was significantly lower with precise APC compared with pulsed APC in vivo. The pulsed effect 2 shows a positive correlation between the penetration depth and the power (r = 0.38, P.0002) or application time for the highest power setting used (40 W, r = 0.77, P.0001). This correlation could not be detected with precise APC because of its very superficial tissue effect.This was an animal study. The distance of the APC probe to the esophagus may have varied between applications in vivo.Thermal damage by APC of the esophageal tunica muscularis seems to be underestimated ex vivo. The extent of tissue injury was significantly lower with precise APC than with pulsed APC, indicating that precise APC may be suitable for the treatment of particularly thermosensitive, thin-wall anatomy.

Bipolar vessel sealing is pivotal in laparoscopic hemostasis. However, major coaptive desiccation parameters have yet to be investigated in detail. The current investigation aims to study the impact of compressive pressure, thermal conduction, and electrical current effects on seal quality in a randomized, controlled experimental trial in an in vitro porcine model of vessel sealing. A total of 106 porcine vessels were sealed with either bipolar current or thermal conduction. Compressive pressure on the sealing site and maximum temperature were varied and monitored. Additionally, the longitudinal vessel tension was measured. The burst pressure of the resulting seal was determined as an indicator of seal quality. In bipolar coaptation, seal quality depends on the compressive pressure applied to the coagulation site in both arteries and veins. The optimal pressure interval was around 270 mN/mm2 for arteries and 200 mN/mm2 for veins. Deviation from these optimal pressures towards low and high extremes led to significantly fewer successful seals. We also found that both maximum coaptation temperature and vessel shrinking correlated with the seal quality. This correlation was reciprocal in arteries and veins. Thermal conduction alone was less successful than sealing by bipolar current. Therefore, compressive pressure during coaptation determines the seal quality. Upper and lower pressure boundaries for safe coaptation exist for both arteries and veins. Vessel sealing by thermal conduction without electrical current effects is possible but represents a less effective method for coaptation. These findings have implications for the rational design of new electrosurgical instruments.