Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma

Complication of Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301048
• Other study ID #: BFHHZS20230203
• Status: Completed
• Start date: November 7, 2023
• Est. completion date: December 7, 2023

Study information

• Verified date: January 2024
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Complication of Treatment
• Duodenal Adenoma

Intervention

Procedure:
• Stent 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of complete resection	The pathological margins results were used to determine whether the lesion was completely resected.	1 week after the operation
Secondary	Rate of recurrence	Endoscopic observation and biopsy results were used to find recurrence.	Within 3 years after the operation