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

August 14, 2023 updated by: Xiuli Zuo, Shandong University

Feasibility and Safety Analysis of Cold Snare Polypectomy in 5-9mm Small Intestinal Polyp Resection in Patients With Peutz-Jeghers Syndrome: A Prospective, Interventional Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold snare polypectomy group
Procedure: Cold snare polypectomy
For eligible patients, use cold snare polypectomy to resect 5-9mm short-pedicled, broad-pedicled or sessile small bowel polyps

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SDU-QILU-G002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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