Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma

NCT06301048 | Completed

• 1 other identifier: BFHHZS20230203
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Duodenal Adenoma; Complication of Treatment

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of complications

  Complications 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.

  through study completion, an average of 1 year

• Rate of complete resection

  The pathological margins results were used to determine whether the lesion was completely resected.

  1 week after the operation

Secondary Outcomes (1)

• Rate of recurrence

  Within 3 years after the operation

Study Arms (4)

Pancreatic Stenting Group

performed pancreatic duct stent placement after endoscopic papillectomy

Procedure: Stent Placement in Pancreatic and Bile Ducts

Non-Pancreatic Stenting Group

have not performed pancreatic duct stent placement after endoscopic papillectomy

Biliary Stenting Group

performed common bile duct stent placement after endoscopic papillectomy

Procedure: Stent Placement in Pancreatic and Bile Ducts

Non-Biliary Stenting Group

have not performed common bile duct stent placement after endoscopic papillectomy

Interventions

Stent Placement in Pancreatic and Bile Ducts PROCEDURE

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.

Biliary Stenting Group; Pancreatic Stenting Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Interventions

Pancreatic Hormones

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Fujing Lv, M.D.

  Beijing Friendship Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 8, 2024
• Study Start: November 7, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-01

Locations

CN (1)