Clinical trial NCT06301048: Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma
Official title: Effectiveness of Endoscopic Papillectomy With Stent Placement in Pancreatic and Bile Ducts for Treating Duodenal Papillary Adenoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Adenoma
Complication of Treatment
Keywords: Duodenal papillary adenoma
Endoscopic duodenal papillectomy
Pancreatic duct stent
Common bile duct stent
Complication
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who diagnosed with duodenal papillary adenoma underwent endoscopic papillectomy and optionally complemented by pancreatic and biliary stent placement at Beijing Friendship Hospital.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of complications
timeFrame: through study completion, an average of 1 year
measure: Rate of complete resection
timeFrame: 1 week after the operation
Secondary outcomes:
measure: Rate of recurrence
timeFrame: Within 3 years after the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Fujing Lv, M.D.
role: STUDY_DIRECTOR
References: