An interventional study of Endoscopic papillectomy with pancreatic duct stent placement and Endoscopic papillectomy with pancreatic duct and biliary stent placement in Post-Procedural Complications, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and efficacy of biliary stent placement combined with pancreatic stent placement versus pancreatic stent alone in patients undergoing endoscopic papillectomy (EP) for duodenal ampullary adenoma. The primary objective is to compare the overall incidence of post-procedural complications between the two groups. A total of 190 patients will be enrolled and randomized 1:1 to receive either pancreatic stent alone (PS group) or combined biliary and pancreatic stents (PBS group).
This is a multicenter, randomized, open-label, parallel-group trial comparing prophylactic biliary plus pancreatic duct stenting versus pancreatic duct stenting alone after endoscopic papillectomy for duodenal ampillary adenoma or early ampullary carcinoma (less than or equal to T1a). Patients are randomized 1:1. In both groups a pancreatic duct stent is placed at the end of the procedure; the experimental group additionally receives a biliary duct stent. Patients are followed up at 3, 6 and 12 months after the initial treatment and annually thereafter for at least 5 years, with side-viewing duodenoscopy, targeted biopsy of the scar and of any abnormal area.
Qilu Hospital of Shandong University is the lead sponsor of 305 studies on the registry; 184 are open to participants now.
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Exclusion Criteria:
Patients undergoing EP followed by pancreatic duct stent placement only.
Procedure: Endoscopic papillectomy with pancreatic duct stent placement
Patients undergoing EP followed by pancreatic duct and biliary stent placement.
Procedure: Endoscopic papillectomy with pancreatic duct and biliary stent placement
Patients undergo standard EP for duodenal ampullary adenoma. A pancreatic duct stent is placed at the end of the procedure; no biliary stent is placed.
Patients undergo standard EP for duodenal ampullary adenoma. Both prophylactic pancreatic duct and biliary stents are placed at the end of the procedure.
Overall incidence of post-procedural complications
The primary outcome is the proportion of patients who develop at least one post-procedural complication (including bleeding, pancreatitis, cholangitis, and perforation) within 30 days after EP . Complications will be graded according to established criteria.
Time frame: Within 30 days after the initial treatment
Incidence of post-procedural pancreatitis
Post-procedural pancreatitis is defined as meeting at least two of the following three criteria: (1) abdominal pain characteristic of acute pancreatitis; (2) serum amylase or lipase \>3 times the upper limit of normal; (3) characteristic imaging findings of pancreatitis on CT or ultrasound. Severity will be classified as mild (interstitial edematous pancreatitis without organ failure or necrosis), moderate (transient organ failure ≤48h and/or local complications), or severe (persistent organ failure \>48h and/or death) per the revised Atlanta classification.
Time frame: Within 30 days after the initial treatment
Incidence of post-procedural bleeding
Post-procedural bleeding is defined as any of the following after achieving primary hemostasis: (1) overt bleeding symptoms (hematemesis, melena, hematochezia, or blood aspirated via nasogastric tube); (2) hemodynamic instability due to bleeding; (3) hemoglobin drop \>2 g/dL; (4) direct endoscopic evidence of bleeding from the papillectomy site.
Time frame: Within 30 days after the initial treatment
Incidence of post-procedural perforation
Post-procedural perforation is defined as evidence of transmural defect detected by emergency endoscopy, or radiological evidence of free air in the retroperitoneum or peritoneal cavity on CT scan.
Time frame: Within 30 days after the initial treatment
Incidence of post-procedural cholangitis
New onset temperature \>38 °C for more than 24 hours combined with cholestasis. Severity will be graded separately according to the TG18 severity classification (Grade I / II / III) and reported descriptively.
Time frame: Within 30 days after the initial treatment
Incidence of biliary stricture
EP-related biliary stricture diagnosed by CT, EUS, or MRCP during follow-up, defined as focal narrowing of the common bile duct with or without proximal dilation.
Time frame: Within 12 months after the initial treatment
Incidence of transient adverse events (TAEs)
Transient adverse events are temporary, reversible procedure-related injuries that do not require medical intervention and do not prolong hospital stay. Includes fever, abdominal pain, nausea, vomiting, and hyperamylasemia (elevated amylase not meeting pancreatitis criteria).
Time frame: Within 7 days after the initial treatment
Recurrence rate
Recurrence is defined as histologically confirmed ampullary adenoma growth at follow-up endoscopy more than 3 months after initial treatment.
Time frame: At 12 months after the initial treatment
Residual rates
Residual is defined as histologically confirmed adenoma growth within 3 months after initial treatment.
Time frame: Within 3 monthsafter the initial treatment
Length of hospital stay
Total number of calendar days spent in hospital from the date of admission for the initial treatment through 12 months after the initial treatment, including the index hospitalization and all readmissions due to disease-related symptoms or treatment-related events.
Time frame: Within 12 months after the initial treatment
Plan to share: No
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University →