Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome

Phase 4

Not yet recruiting

• Conditions: Peutz-Jeghers Syndrome; Small Bowel Polyp
• Interventions: Procedure: Cold snare polypectomy

• Registration Number: NCT06001476
• Lead Sponsor: Shandong University

Brief Summary

This study aims to evaluate the feasibility and safety of Cold snare polypectomy for removing 5-9mm small intestinal polyps in patients with Peutz-Jeghers Syndrome (PJS),in order to provide some reference for clinical strategy of endoscopic treatment of small intestinal polyps in PJS patients, and may prolong the follow-up period of PJS patients Intervals.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Last Update Submitted: 2023-08-14
• Study Start: 2023-08-20
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 8-60, male or female.
• Diagnosed with Peutz-Jeghers Syndrome
• Undergo enteroscopy for small bowel polypectomy.

Exclusion Criteria

• Absence of at least one study polyp (5-9mm stubby pedicle, wide pedicle and sessile small bowel polyps);
• Be evaluated during enteroscopy for requiring surgical intervention (such as endoscopically difficult to handle giant polyps, intussusception, etc.)；
• With more than 50 polyps ≥1cm found in this enteroscopy examination;
• The polyp has been confirmed to be malignant by pathology, or highly suspicious of malignant transformation under endoscopy;
• Receiving anticoagulant therapy during this treatment;
• Unable or unwilling to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cold snare polypectomy group	Cold snare polypectomy	-

Primary Outcome Measures

Name	Time	Method
Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS	28 days after the procedure	The complications include complications during CSP and complications occurring within 28 days after enteroscopy

Secondary Outcome Measures

Name	Time	Method
Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy	Immediately after the procedure	Including intraoperative bleeding (defined as active haemorrhage for more than 30s), perforation immediately, etc.
Incidence of complications within 28 days after enteroscopy	28 days after the procedure	Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China