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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting

Study contacts

• Study coordinator: Qiao Mei, MD
• Email: meiqiaomq@aliyun.com
• Phone: 8613865977696

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-stay aggressive hydration to prevent post-ERCP pancreatitis

  This trial tests whether a short, high-volume IV hydration with Lactated Ringer's plus a rectal indomethacin can prevent post-ERCP pancreatitis in adults undergoing ERCP.

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• Low-dose versus standard-dose indomethacin to prevent pancreatitis after ERCP

  This test sees if a lower rectal dose of indomethacin prevents pancreatitis as well as the standard 100 mg dose in adults undergoing ERCP.

  Recruiting at 3 sites Phase 4 Changhai Hospital · Shanghai and 11 other locations · NCT07088757

• Comparing Indomethacin and Pancreatic Stenting to Prevent Post ERCP Pancreatitis

  This study is testing whether giving indomethacin through the rectum or using pancreatic stenting is better at preventing pancreatitis after a procedure called ERCP in patients who are at high risk for this complication.

  Recruiting at 6 sites Phase 3 Chinese University of Hong Kong · Xi'an, Shaanxi and 6 other locations · NCT03713879

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.