Cholelithiasis Associated With Common Bile Duct Stones
Conditions
Keywords
Cholelithiasis with Concomitant Choledocholithiasis, Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy, post-ERCP pancreatitis, Randomized Controlled Trial (RCT)
Brief 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.
Interventions
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.
DRUGrectal indomethacin alone
rectal indomethacin was used alone in the control group
Sponsors
Qilu Hospital of Shandong University
The Affiliated Hospital of Qingdao University
Linyi People's Hospital
Rizhao People's Hospital
Taian City Central Hospital
Shandong Province Third hospital
Binzhou Medical University
Liaocheng People's Hospital
Weifang People's Hospital
Central Hospital of Zibo
Qianfoshan Hospital
Qilu Hospital of Shandong University (Qingdao)
Qingdao Municipal Hospital
Shengli Oilfield Hospital
The Second Hospital of Shandong University
Dezhou Hospital Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years or older; 2. Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI); 3. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones; 4. Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP; 5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm; 6. Patients with at least one of the following high-risk factors for post-ERCP pancreatitis (PEP): suspected sphincter of Oddi dysfunction (SOD), female sex, history of pancreatitis, difficult cannulation (defined as ≥5 cannulation attempts or ≥5 minutes of cannulation time), pancreatic duct contrast injection, age \<35 years, non-dilated extrahepatic bile duct, no history of chronic pancreatitis, normal serum bilirubin, precut sphincterotomy, biliary balloon dilation, incomplete bile duct stone clearance, or intraductal ultrasound ; 7. Patients who voluntarily provide signed informed consent.
Exclusion criteria
1. Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome; 2. Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations; 3. Patients unfit for ERCP endoscopic treatment due to severe systemic diseases; 4. Patients with severe coagulation dysfunction (defined as an International Normalized Ratio \[INR\] \>1.5) or significant thrombocytopenia (platelet count \<50×10⁹/L); 5. Pregnant women; 6. Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure; 7. Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs); 8. Patients with congenital or acquired absence of the rectum; 9. Patients with severe acute pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients with Post-ERCP Pancreatitis | 24 hours to 72 hours after ERCP | If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis | Within 1 months after ERCP | The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention. |
| Clinical Success Rate | Within 1 months after ERCP | Complete removal of gallbladder stones. |
| The Proportion of Patients with Other Complications | Within 6 months after ERCP | Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc. |
Countries
China
Contacts
CONTACTZhen Li, MD
PRINCIPAL_INVESTIGATORTao Yu, MD
Qilu Hospital of Shandong University
Outcome results
None listed