Comparing early and late pancreatic stent placement to prevent post-ERCP pancreatitis

Early Versus Late Pancreatic Stent Placement for Preventing Post-ERCP Pancreatitis: a Multicentre, Randomised Trial

This study is testing whether placing a pancreatic stent right after a procedure or later can help prevent pancreatitis in patients who have a difficult time with bile duct access.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 768 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Anhui Medical University (other)
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT06250803 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness of early versus late pancreatic stent placement in preventing post-endoscopic retrograde cholangiopancreatography (PEP) in patients with naive papilla undergoing challenging biliary access. A total of 768 patients will be randomly assigned to receive either early pancreatic stent placement immediately after endoscopic procedures or late placement after all therapeutic interventions. The primary focus is on measuring the rate and severity of PEP, while secondary outcomes will also be assessed. The study will take place across four participating centers, ensuring a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with naive papilla undergoing ERCP using a pancreatic guidewire-assisted technique.

Not a fit: Patients with conditions such as unreachable main papillae, surgically altered gastrointestinal anatomy, or concurrent acute pancreatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of post-ERCP pancreatitis, improving patient outcomes and recovery times.

How similar studies have performed: While the specific timing of pancreatic stent placement is being evaluated in this trial, similar studies have shown promising results in reducing post-ERCP pancreatitis, indicating a potential for success.

Eligibility criteria

Inclusion Criteria:

Participants who fulfill all the below criteria will be enrolled: 1. with naive papilla; 2. over 18 years; 3. undergoing ERCP with pancreatic guidewire-assisted technique for biliary access; 4. providing a signed, written informed consent.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded: 1. unreachable main papillae; 2. surgically altered gastrointestinal anatomy; 3. concurrent acute pancreatitis; 4. biliary cannulation over pancreatic duct stent after precut sphincterotomy or wire-guided method (native early attribute); 5. failed biliary cannulation; 6. severe active cardiopulmonary disease; 7. breastfeeding or pregnancy; 8. ampullary tumour.

Where this trial is running

Hefei, Anhui and 1 other locations

• Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Qiao Mei, MD

Conditions: Cholangiopancreatography, Endoscopic Rretrograde, Post-ERCP Pancreatitis, pancreatic stent, post-ERCP pancreatitis