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

Summary

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.

Conditions

• Cholelithiasis Associated With Common Bile Duct Stones

Interventions

DEVICE

Prophylactic pancreatic stent

All procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although the technical approach, including the amount of time and effort expended for this purpose, was not standardized.All patients received 100mg indomethacin suppositories.

DRUG

rectal indomethacin alone

rectal indomethacin was used alone in the control group

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• Rizhao People's Hospital

  collaborator OTHER

• Taian City Central Hospital

  collaborator OTHER

• Shandong Province Third hospital

  collaborator OTHER

• Binzhou Medical University

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Central Hospital of Zibo

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University (Qingdao)

  collaborator OTHER

• Qingdao Municipal Hospital

  collaborator OTHER

• Shengli Oilfield Hospital

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Dezhou Hospital Qilu Hospital of Shandong University

  collaborator OTHER

• Qilu Hospital of Shandong University

  lead OTHER

Principal Investigators

• Tao Yu, MD · Qilu Hospital of Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• China

Study Locations