Quality-of-Life and Recurrence Outcomes Following Laparoscopic Elective Sigmoid Resection vs Conservative Treatment Following Diverticulitis: Prespecified 2-Year Analysis of the LASER Randomized Clinical Trial.

Importance: Both elective sigmoid resection and conservative treatment are options for patients with recurrent, complicated, or persistent painful diverticulitis; understanding outcomes following each can help inform decision-making. Objective: To compare outcomes of elective sigmoid resection and conservative treatment for patients with recurrent, complicated, or persistent painful diverticulitis at 2-year follow-up. Design, Setting, and Participants: This multicenter parallel open-label individually randomized clinical trial comparing elective sigmoid resection to conservative treatment in patients with recurrent, complicated, or persistent painful diverticulitis was carried out in 5 Finnish hospitals between September 2014 and October 2018. Follow-up up to 2 years is reported. Of 85 patients randomized and included, 75 and 70 were available for QOL outcomes at 1 year and 2 years, respectively, and 79 and 78 were available for the recurrence outcome at 1 year and 2 years, respectively. The present analysis was conducted from September 2015 to June 2022. Interventions: Laparoscopic elective sigmoid resection vs conservative treatment (patient education and fiber supplementation). Main Outcomes and Measures: Prespecified secondary outcomes included Gastrointestinal Quality of Life Index (GIQLI) score, complications, and recurrences within 2 years. Results: Ninety patients (28 male [31%]; mean [SD] age, 54.11 [11.9] years and 62 female [69%]; mean [SD] age, 57.13 [7.6] years) were randomized either to elective sigmoid resection or conservative treatment. After exclusions, 41 patients in the surgery group and 44 in the conservative group were included in the intention-to-treat analyses. Eight patients (18%) in the conservative treatment group underwent sigmoid resection within 2 years. The mean GIQLI score at 1 year was 9.51 points higher in the surgery group compared to the conservative group (mean [SD], 118.54 [17.95] vs 109.03 [19.32]; 95% CI, 0.83-18.18; P = .03), while the mean GIQLI score at 2 years was similar between the groups. Within 2 years, 25 of 41 patients in the conservative group (61%) had recurrent diverticulitis compared to 4 of 37 patients in the surgery group (11%). Four of 41 patients in the surgery group (10%) and 2 of 44 in the conservative group (5%) had major postoperative complications within 2 years. In per-protocol analyses, the mean (SD) GIQLI score was higher in the surgery group compared to the conservative treatment group by 11.27 points at 12 months (119.42 [17.98] vs 108.15 [19.28]; 95% CI, 2.24-20.29; P = .02) and 10.43 points at 24 months (117.24 [15.51] vs 106.82 [18.94]; 95% CI, 1.52-19.33; P = .02). Conclusions and Relevance: In this randomized clinical trial, elective sigmoid resection was effective in preventing recurrent diverticulitis and improved quality of life over conservative treatment within 2 years. Trial Registration: ClinicalTrials.gov Identifier: NCT02174926.

Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis: The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial.

Importance: Diverticulitis has a tendency to recur and affect quality of life. Objective: To assess whether sigmoid resection is superior to conservative treatment in improving quality of life of patients with recurrent, complicated, or persistent painful diverticulitis. Design, Setting, and Participants: This open-label randomized clinical trial assessed for eligibility 128 patients with recurrent, complicated, or persistent painful diverticulitis in 6 Finnish hospitals from September 29, 2014, to October 10, 2018. Exclusion criteria included age younger than 18 years or older than 75 years; lack of (virtual) colonoscopy or sigmoidoscopy data within 2 years, or presence of cancer, contraindication to laparoscopy, or fistula. Outcomes were assessed using intention-to-treat analysis. A prespecified interim analysis was undertaken when 66 patients had been randomized and their 6-month follow-up was assessable. Data were analyzed from June 2018 to May 2020. Interventions: Laparoscopic sigmoid resection or conservative treatment. Main Outcomes and Measures: The primary outcome was difference in Gastrointestinal Quality of Life Index (GIQLI) score between randomization and 6 months. Results: Of 128 patients assessed for eligibility, 90 were randomized (28 male [31%]; mean [SD] age, 54.11 [11.9] years; 62 female [69%]; mean [SD] age, 57.13 [7.6] years). A total of 72 patients were included in analyses for the primary outcome (37 in the surgery group and 35 in the conservative treatment group), and 85 were included in analyses for clinical outcomes (41 in the surgery group and 44 in the conservative treatment group). The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76 [15.89] points vs -0.2 [19.07] points; difference, 11.96; 95% CI, 3.72-20.19; P = .005). Four patients (10%) in the surgery group and no patients in the conservative treatment group experienced major complications (Clavien-Dindo grade III or higher). There were 2 patients (5%) in the surgery group and 12 patients (31%) in the conservative treatment group who had new episodes of diverticulitis within 6 months. Conclusions and Relevance: In this randomized clinical trial, elective laparoscopic sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but carried a 10% risk of major complications. Trial Registration: ClinicalTrials.gov Identifier: NCT02174926.

Criteria for difficult biliary cannulation: start to count.

OBJECTIVE: In European Society of Gastrointestinal Endoscopy guidelines, biliary cannulation of native papilla is defined as difficult in the presence of >5 papilla contacts, >5 min cannulation time or >1 unintended pancreatic duct cannulation (5-5-2). The aim is to test 5-5-2-criteria in a single-center practice predicting the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), and to study the efficacy of transpancreatic biliary sphincterotomy (TPBS) as an advanced method for biliary cannulation. METHODS: Prospectively collected data of 821 patients with native papilla were analyzed. Primary cannulation was the first method chosen for cannulation (sphincterotome and a guidewire). Advanced cannulation method was endoscopist-chosen cannulation method after failed primary cannulation. RESULTS: Primary cannulation succeeded in 599 (73%) patients in a median of 2 min. TPBS ± needle knife resulted in a 90% success rate. The final cannulation success was 814 (99.1%) cases in a median of 5.3 min. PEP risk was 4.0%. When primary cannulation succeeded, the PEP rate was 2.3%. When advanced methods were needed, the PEP rate increased to 13.5%. Altogether 311 (37.9%) patients fulfilled at least one 5-5-2-criterion. In patients without 5-5-2-criteria, the primary cannulation succeeded in 79.6% (n = 477), compared to 20.4% (n = 122) with the criteria, P < 0.001, indicating the need to exchange the cannulation method instead of persistence. If all the 5-5-2-criteria were present, the risk of PEP was 12.7%. CONCLUSION: The results support the use of the 5-5-2-criteria for difficult cannulation. TPBS is an effective advanced cannulation method with an acceptable complication rate.

Endoscopic papillectomy, single-centre experience.

BACKGROUND: Endoscopic removal of benign tumours of papilla is increasing. Our aim was to evaluate the outcome of endoscopic resection of papillary tumours. METHODS: In the years 2000-2012, 61 papillectomies were performed in Helsinki University Central Hospital. The cases were analysed retrospectively. RESULTS: There were 35 patients with benign tumour of papilla without familial adenomatous polyposis (FAP), 16 patients with FAP and 10 patients with ampullary cancer. Jaundice and bile duct dilation were risk factors for malignancy (p < 0.001). In benign tumours, the recurrence rate was 25.5 %. In 5/51 benign tumour cases (9.8 %), a pancreaticoduodenectomy was performed. The remaining cases were treated endoscopically. Neither tumour size, resection in one piece or piecemeal technique, nor coagulation of resection margins had an effect on the development of residual tumour. The total complication rate was 24.6 %. Pancreatitis developed in six patients (9.8 %, 3 mild and 3 moderate). In benign tumour cases, pancreatic stent decreased pancreatitis rate (p = 0.045). In cases where only a pancreatic sphincterotomy was performed, the risk of pancreatitis was high 4/7 (57 %). Bleeding was the most common complication (18 %). Only one patient was operated due to complication, a post-papillectomy bleeding. In six out of seven non-operated cancer patients, the disease progressed. CONCLUSION: Endoscopic papillectomy is an effective procedure for treating benign papillary tumours. Jaundice and bile duct dilation are more common in malignant tumours. Pancreatic stent decreases the risk of post-papillectomy pancreatitis. Pancreatic sphincterotomy without stenting carries a high risk of pancreatitis. For papillary cancer, surgery is recommended.