Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. The study aims to analyze the impact of pancreatic duct stent implantation on the incidence of post-ERCP pancreatitis in gallstone patients treated with ERCP-GPC by comparing the efficacy differences between the experimental and control groups. Additionally, the study investigate the effects of pancreatic duct stent placement post-ERCP on other postoperative complications, conduct a comparative analysis of the economic benefits of placing versus not placing pancreatic duct stents after ERCP, and develop effective clinical strategies for preventing pancreatitis after gallbladder-preserving stone extraction in gallstone patients.

Eligibility criteria

Qualifiers

Patients aged 18 years or older;

Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);

Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;

Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;

Disqualifiers

Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;

Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;

Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;

Patients with severe coagulation dysfunction (defined as an International Normalized Ratio [INR] >1.5) or significant thrombocytopenia (platelet count <50×10⁹/L);

Trial design

Treatments tested in this trial

  • Prophylactic pancreatic stent
  • rectal indomethacin alone

Treatment groups

88 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Qilu Hospital of Shandong University

Lead sponsor

The Affiliated Hospital of Qingdao University

Collaborator

Linyi People's Hospital

Collaborator

Rizhao People's Hospital

Collaborator

Taian City Central Hospital

Collaborator

Shandong Province Third hospital

Collaborator

Binzhou Medical University

Collaborator

Liaocheng People's Hospital

Collaborator

Weifang People's Hospital

Collaborator

Central Hospital of Zibo

Collaborator

Qianfoshan Hospital

Collaborator

Qilu Hospital of Shandong University (Qingdao)

Collaborator

Qingdao Municipal Hospital

Collaborator

Shengli Oilfield Hospital

Collaborator

The Second Hospital of Shandong University

Collaborator

Dezhou Hospital Qilu Hospital of Shandong University

Collaborator