Skip to content

Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma

Effectiveness of Endoscopic Papillectomy With Stent Placement in Pancreatic and Bile Ducts for Treating Duodenal Papillary Adenoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06301048
Enrollment
79
Registered
2024-03-08
Start date
2023-11-07
Completion date
2023-12-07
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Treatment, Duodenal Adenoma

Keywords

Duodenal papillary adenoma, Endoscopic duodenal papillectomy, Pancreatic duct stent, Common bile duct stent, Complication

Brief summary

This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates.

Detailed description

Duodenal papillary adenoma, a potentially malignant benign tumor is primarily treated with endoscopic papillectomy. Despite its efficacy, endoscopic papillectomy has a high complication rate. This study investigates whether pancreatic duct and common bile duct stent placement can mitigate these complications. In a retrospective analysis, 79 patients with duodenal papillary adenoma, treated with endoscopic papillectomy at our center, were studied. The cohort included patients who underwent endoscopic papillectomy with no stents placement, common bile duct stent placement alone, pancreatic duct stent placement alone, or stents placement in both ducts. Complete resection rates did not significantly differ between patients with or without stent placement. Early complication rates were similar across groups. However, significant reduction in common bile duct stenosis was observed in the stenting group. Furthermore, stent placement correlated with lower adenoma recurrence rates during follow-up. Thus, Pancreatic duct and common bile duct stent placement in endoscopic papillectomy may decrease late complications, particularly common bile duct stenosis, and reduce the recurrence of duodenal papillary adenoma.

Interventions

PROCEDUREStent Placement in Pancreatic and Bile Ducts

Post-resection, endoscopic retrograde cholangiopancreatography (ERCP) was performed for stent placement in pancreatic or bile ducts as needed, with X-ray confirmation of stent positioning.

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years. * Identification of duodenal papillary lesions via gastroscopy or duodenoscopy. * Intraductal involvement \<20mm. * Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging). * Postoperative biopsy confirming adenoma.

Exclusion criteria

* Diagnosis of familial adenomatous polyposis or multiple hamartoma syndrome. * Patients undergoing pancreaticoduodenectomy within a month post-EP for residual lesions.

Design outcomes

Primary

MeasureTime frameDescription
Rate of complicationsthrough study completion, an average of 1 yearComplications related with Endoscopic Papillectomy (EP), including pancreatitis, cholangitis, bleeding, perforation, hyperamylasemia, stenosis. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination during follow-up were measured.
Rate of complete resection1 week after the operationThe pathological margins results were used to determine whether the lesion was completely resected.

Secondary

MeasureTime frameDescription
Rate of recurrenceWithin 3 years after the operationEndoscopic observation and biopsy results were used to find recurrence.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026