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Background: Transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE. Methods: Forty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3years are reported in this study (PP- and ITT-analysis). Results: TIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year. Conclusion: TIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases. ClinicalTrials.Gov: ID: NCT03669874.

Endoscopic submucosal dissection (ESD) represents the method of choice for removal of large colorectal neoplasms with suspected submucosal invasion. Presence and degree of submucosal fibrosis increases ESD duration and technical complexity, reduces the rate of curative resection and reduces safety profile. The aim of the study was to identify pre-procedural predictive factors of submucosal fibrosis in naïve colorectal neoplasms and to assess the impact of fibrosis on technical and clinical ESD outcomes.All consecutive ESD performed between 2014 and 2021 were retrieved from a prospectively collected database. For each patient, pre-procedural, procedural, and post-procedural data were recorded. Logistic regression was used to identify pre-procedural predictive factors for submucosal fibrosis. The study was approved by Institutional Reviewer Board and registered on ClinicalTrials.gov (NCT04780256).One hundred-74 neoplasms (46.6% rectum, 21.8% left colon, 31.6% right colon; size 34.9 ± 17.5 mm) from 169 patients (55.0% male; 69.5 ± 10.4-year-old) were included. 106 (60.9%) neoplasms were granular type laterally spreading tumor (LST-G), 42 (24.1%) non-granular (LST-NG), and 26 (14.9%) sessile; invasive pit pattern was observed in 90 (51.7%) lesions. No fibrosis (F0) mild (F1) and severe (F2) were observed in 62 (35.6%), 92 (52.9%), and 20 (11.5%), respectively. Left colonic localization [OR 3.23 (1.1-9.31)], LST-NG morphology [OR 5.84 (2.03-16.77)] and invasive pit pattern [OR 7.11 (3.11-16.23)] were independently correlated to submucosal fibrosis. Lower curative resection rate (59.8% vs. 93.5%, P 0.001) was observed in case of fibrosis; the incidence of adverse events was higher in case of severe fibrosis (35.5%) compared to no (3.2%) and mild fibrosis (3.3%; P 0.001). Procedure time was significantly impacted by presence and degree of fibrosis (P 0.001).Left colonic localization, LST-NG morphology, and invasive pit pattern are independent predictors of fibrosis, affecting technical and clinical ESD outcomes. Pre-procedural stratification is pivotal to estimate procedure time, required operator's experience and advanced dissection techniques. Cecinato P et al. Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of colorectal neoplasms before endoscopic submucosal dissection. Surg Endosc. 2023.

Background Endoscopic retrograde cholangiopancreatography (ERCP) with the placement of a biliary stent is the treatment of choice for palliation of malignant obstructive jaundice. In 5–10% of cases ERCP fails. In these cases an effective alternative is endoscopic ultrasonography-guided biliary drainage (EUS-BD). Aim Evaluation of the principal clinical outcomes of direct transluminal EUS-BD. Patients and methods This study is a retrospective analysis. All consecutive patients with malignant obstructive jaundice, in whom ERCP had failed, were enrolled. The primary outcome was the technical success of EUS-BD defined as the correct placement of the metal or plastic stent across the stomach or duodenum to the biliary tree. The most important secondary outcomes were early and late clinical success, both linked to the decrease of bilirubin haematic level. Results Between January 2011 and November 2017 thirty-six patients were included. Technical success was obtained in 91.6%. A clinical success, early or late was obtained in 75.8%. The ECOG performance status of less than 3 was correlated with clinical success. Adverse events occurred in 30.3% of patients. Conclusions EUS-BD is an effective and safe procedure.

Ampullary adenomas are rare and potentially malignant. Surgery was the standard treatment but endoscopic papillectomy (EP) is a possible alternative. We retrospectively evaluated the principal clinical outcomes of EP in all patients referred to our unit also dividing sporadic ampullary adenoma (SAA) from familial adenomatous polyposis (FAP)–associated adenomas. All consecutive patients who underwent endoscopic papillectomy because of ampullary adenoma were considered. The primary outcome was the technical success of EP. Secondary outcomes included the number of procedures, the adverse event rate, the recurrence rate, the concordance of histology pre- and post-EP, and the evaluation of factors related to technical success. Between January 2001 and December 2015, sixty-two patients were included (21 FAP and 41 SAA). Technical success was achieved in 75.8% and was different in the two groups (FAP 95.2%, SAA 65.8%, p 0.025). Intraductal invasion was negatively associated with technical success (41.7% vs. 84.0%; p 0.005). The intestinal subtype was predictive of success (79.7% vs. 0%; p 0.012) as well as en bloc resection (90.3% vs. 61.3%; p 0.016). Adverse events were reported in 14 patients (22.6%). EP is an effective and safe procedure and is a viable alternative to surgery. ClinicalTrials.gov Identifier: NCT03494543

BACKGROUND AND STUDY AIMS: The study aimed to investigate whether the 25G needle is superior to the 22G needle when used in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of solid lesions. PATIENTS AND METHODS: The study was a single-center randomized clinical trial. The setting was a tertiary referral hospital, where EUS-FNA of solid lesions was assisted by an on-site cytopathologist, who was blinded to the needle size. The main end point was the number of passes performed to obtain adequate samples. Crossover to the other type of needle was allowed after five passes, or when the gastroenterologist experienced difficulties in puncturing the lesions. RESULTS: A total of 129 solid lesions were randomized and data regarding 127 lesions were analyzed. The mean number of passes was 3.7 (± 1.9) in the 22G needle group and 3.8 (± 2) in the 25G needle groups (difference of means: 0.1; 95 %CI: – 0.59 to 0.79). Fifty-eight of 63 (92.1 %) and 60/64 samples (93.7 %) in the 22G and 25G needle groups respectively were adequate (difference: – 1.6 %; 95 %CI: – 12.1 % to 8.9 %). Crossover to the other type of needle was performed in 11/63 (17.5 %) and in 12/64 (18.7 %) lesions in the two groups respectively (difference: – 1.2 %; 95 %CI: – 16.2 % to 13.8 %). A crossover to the 25G needle was successfully performed in four masses in the uncinate process; these lesions were difficult to puncture using the 22G needle. CONCLUSIONS: Our study failed to demonstrate that the 25G is more effective than the 22G needle in EUS-FNA of solid lesions. However, targeting of lesions in the distal duodenum may be simplified by using the 25G needle.

BACKGROUND AND STUDY AIMS Despite the increasing use of early esophagogastroduodenoscopy, the prognostic evaluation and triage of patients who have ingested caustic material is challenging. We evaluated the usefulness of selected clinical and endoscopic parameters in predicting the risk of death after ingestion of caustic substances. PATIENTS AND METHODS Clinical and endoscopic parameters were obtained from the records of all the patients admitted to our endoscopy unit because of ingestion of caustic material between 1 March 1982 and 30 June 1999. Parameters significantly associated with the risk of death by univariate analysis were entered into a multivariate logistic model. The independent predictors of death by multivariate analysis were used to build a risk score system. RESULTS Out of 210 patients, 13 underwent emergency surgery (6.2 %) and 25 died (11.9 %). Multivariate analysis identified the following as independent predictors of death: age (10-year intervals; odds ratio [OR] 2.4; 95 % confidence interval 1.4 - 4.1), ingestion of strong acids (OR 7.9; 1.8 - 35.3), white blood cell count at admission > or = 20 000 units/mm3 (OR 6.0; 1.3-28), deep gastric ulcers (OR 9.7; 1.4 - 66.8), and gastric necrosis (OR 20.9; 4.7 - 91.8). The values of the risk score system devised from the results of the multivariate analysis ranged from 1 to 16. No patient scoring 14 points survived. CONCLUSION Age, ingestion of a strong acid, leucocytosis, deep gastric ulcers, and gastric necrosis are predictive of death after caustic ingestion. A risk score system including these predictors may be useful in prognostic evaluation.

A 63-year-old woman was admitted to our gastroenterology unit to undergo a screening colonoscopy, scheduled for faecal occult blood test positivity. During the procedure, a flat, rectal granular lesion was found. With the use of magnification and narrow band image (NBI) technology, the lesion was diagnosed as a laterally spreading tumour (LST), granular mixed type, 30 mm in maximum diameter (figure 1). The pit pattern was unclassifiable and vascular pattern was similar to the type IV of the classification proposed by Inoue regarding the microvasculature pattern of the oesophagus for diagnosis and evaluation of the squamous cell carcinoma. The …

AIM: To determine the efficacy of our therapeutic strategy for Helicobacter pylori (H. pylori) eradication and to identify predictive factors for successful eradication. METHODS: From April 2006 to June 2010, we retrospectively assessed 2428 consecutive patients (1025 men, 1403 women; mean age 55 years, age range 18-92 years) with gastric histology positive for H. pylori infection referred to our unit for 13-C urea breath test (UBT), after first-line therapy with proton pump inhibitor (PPI) b.i.d. + amoxicillin 1 g b.i.d. + clarithromycin 500 mg b.i.d. for 7 d. Patients who were still positive to UBT were recommended a second-line therapy (PPI b.i.d. + amoxicillin 1 g b.i.d. + tinidazole 500 mg b.i.d. for 14 d). Third choice treatment was empirical with PPI b.i.d. + amoxicillin 1 g b.i.d. + levofloxacin 250 mg b.i.d. for 14 d. RESULTS: Out of 614 patients, still H. pylori-positive after first-line therapy, only 326 and 19 patients respectively rechecked their H. pylori status by UBT after the suggested second and third-line regimens. “Per protocol” eradication rates for first, second and third-line therapy were 74.7% (95% CI: 72.7%-76.4%), 85.3% (95% CI: 81.1%-89.1%) and 89.5% (95% CI: 74.9%-103%) respectively. The overall percentage of patients with H. pylori eradicated after two treatments was 97.8% (95% CI: 97.1%-98.4%), vs 99.9% (95% CI: 99.8%-100%) after three treatments. The study found that eradication therapy was most effective in patients with ulcer disease (P < 0.05, P = 0.028), especially in those with duodenal ulcer. Smoking habits did not significantly affect the eradication rate. CONCLUSION: First-line therapy with amoxicillin and clarithromycin produces an H. pylori eradication rate comparable or superior to other studies and second-line treatment can still be triple therapy with amoxicillin and tinidazole.

Summary Background & aims Endoscopic submucosal dissection (ESD) was developed for en bloc resection of superficial neoplasm of the digestive tract. We evaluated feasibility and safety of ESD, as a salvage therapy of large refractory rectal polyps, in a tertiary care setting. Methods We prospectively enrolled in the present study and treated by ESD 11 consecutive patients with rectal polyps (median diameter 3.5 cm; range 2–5 cm), who had previously undergone several attempts of endoscopic resection and not suitable for further standard endoscopic treatment. The ESD was carried out with a standard needle knife. Follow up examinations were scheduled at 3, 6, 12 and 24 months. Results We achieved apparently complete resection of polyps in 10/11 patients. In one patient ESD was interrupted and the pathology of the resected fragment showed deep submucosal infiltration; this patient underwent surgery. Deep and lateral margins were shown to be free of neoplasm (radical resection) in six out of 11 patients. However all the 10 patients with apparently complete resection were free of recurrence after a mean follow up of 19.2 months (12–24). A T1 adenocarcinoma was radically resected by ESD, with no recurrence. We recorded 2 cases of subcutaneous emphysema, both treated conservatively. Conclusions Radical resection is difficult to be achieved by ESD in patients with rectal scar-embedded polyps. Nevertheless ESD may be proposed as a definitive treatment of selected patients with refractory polyps, avoiding surgery in the majority of them.

Background and aim. Gastroduodenal ulcer bleeding is the major cause of endoscopic examination on emergency. Patients with acute upper gastrointestinal haemorrhage (UGIH) are routinely hospitalized regardless of the clinical status or the stigmata of bleeding. The Rockall's score (1) was recently tested for its prognostic value after UGIH. The aim of the present study was to validate Rockall's score in a set of patients with gastroduodenal ulcer bleeding in an Italian teaching hospital and to prove his usefulness in improving quality of care. Material and methods. From May/96 to May/97 100 consecutive patients, admitted as emergencies for UGIH, underwent endoscopy within 6 hours of admission and were found affected by gastroduodenal ulcer (peptic or malignant). All the patients with active bleeding (42) and most of the ones with stigmata of recent haemorrhage were treated endoscopically by injection of 10-20 ml 1:10,000 adrenaline. Initial Rockall's score (iR - based on age and presence of shock and comorbidity) and total Rockall's score (tR - sum of iR and a score related to endoscopic findings) were calculated for each patient. Results. Initial haemostasis was achieved in all cases, but 19 patients recurred; 12 died, 9 after at least one rebleeding. Median iR and median tR were 2 (range 0-6) and 4 (1-9) for non-rebleeders vs. 3 (0-7) and 6 (3-10) for rebleeders ( p 8 rebled and died. The average length of hospital stay was 10.3 days for all patients and 4.4 for the group with tR