Alterations in the management for patients with retroduodenal perforations after transpapillary interventions

Aim. To evaluate treatment results of retroduodenal perforations after transpapillary endoscopic procedures, considering new possibilities of modern minimally invasive interventions.Materials and methods. Perforations were identified in 29(0,5%) cases from 5943 endoscopic retrograde procedures in Moscow City Hospital №31 since 01.01.2010 to 01.01.2021. There were 24(82,8 %) women and 5(17,2%) men in the age from 29 to 89 years (median age – 64.2 ± 14.9 years) Endoscopic papillosphincterotomy was performed n 25 (86.2%) cases (in 5 – incisional), with additional lithoextraction in 12 (46.7%), endoscopic papillectomy – in 4 (10%) cases. Perforations developed in 27 (93,1%) patients with two and more risk factors.Results. Combination of endoscopic and conservative treatment was applied to cure the perforation in 24 cases (82.8%). A fully covered self-expandable metal stent was placed in 16 (66.7%) cases, and clips were applied to stenting in 2(8.3%) cases. Isolated endocliping was performed in 5 (20.8%) patients, and a plastic biliary stent – in 1(4.2%) case. Other 5(17.2%) patients underwent conservative (3) and surgical (2) treatment only. Satisfactory results were achieved in 23(79.3%) cases, when combination of endoscopic and conservative therapy was performed. Mortality was observed in 6(20.7%) cases (isolated conservative therapy (3), surgical treatment (2) and endoscopic placement of a plastic biliary stent (1).Conclusion. Retroduodenal perforations can lead to death in 20.7% cases, according to our data. Timely diagnosis and using a combination of conservative and endoscopic methods as biliary stenting with fully covered self-expandable metal stent and endocliping allowed to achieve recovery in all cases.

Trial protocol: a randomised controlled trial to verify the non-inferiority of a partially covered self-expandable metal stent to an uncovered self-expandable metal stent for biliary drainage during neoadjuvant therapy in patients with pancreatic cancer with obstructive jaundice (PUN-NAC trial)

IntroductionNeoadjuvant chemotherapy or neoadjuvant chemoradiotherapy (NAC/NACRT) for resectable/borderline resectable pancreatic cancers was recently performed to improve clinical outcomes and led to good results, although it remains controversial whether NAC/NACRT is beneficial for resectable pancreatic cancer. A few recent studies revealed longer patency and lower cost related to the stent occlusion of a metal stent than those of a plastic stent during NAC/NACRT. It also remains controversial which type of self-expandable metal stent (SEMS) is the most suitable for patients with resectable/borderline resectable pancreatic cancer during NAC/NACRT: an uncovered SEMS (USEMS), a fully covered SEMS (FCSEMS) or a partially covered SEMS (PCSEMS). So far, two randomised controlled trials indicated that a USEMS and an FCSEMS were similar in preoperative stent dysfunction and adverse event rate. Thus, we aimed to verify the non-inferiority of a PCSEMS to a USEMS in this multicentre randomised controlled trial.Methods and analysisWe designed a multicentre randomised controlled trial, for which we will recruit 100 patients with resectable/borderline resectable pancreatic cancer and distal biliary obstruction scheduled for NAC/NACRT from 13 high-volume institutions. Patients will be randomly allocated to the PCSEMS group or USEMS group. The primary outcome measure is the preoperative biliary event rate. Data will be analysed after completion of the study. We will calculate the 95% CIs of the incidence of preoperative biliary events in each group and analyse whether the difference between them is within the non-inferiority margin (10%).Ethics and disseminationThis study has been approved by the institutional review board of Hokkaido University Hospital. The results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal.Trial registration numberUMIN000041737; jRCT1012200002.