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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06001476
Enrollment
40
Registered
2023-08-21
Start date
2023-08-20
Completion date
2025-02-01
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peutz-Jeghers Syndrome, Small Bowel Polyp

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.

Interventions

For eligible patients, use cold snare polypectomy to resect 5-9mm short-pedicled, broad-pedicled or sessile small bowel polyps

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS28 days after the procedureThe complications include complications during CSP and complications occurring within 28 days after enteroscopy

Secondary

MeasureTime frameDescription
Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomyImmediately after the procedureIncluding intraoperative bleeding (defined as active haemorrhage for more than 30s), perforation immediately, etc.
Incidence of complications within 28 days after enteroscopy28 days after the procedureIncluding Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026