Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome
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| ClinicalTrials.gov Identifier: NCT06001476 |
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Recruitment Status :
Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
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Sponsor:
Shandong University
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peutz-Jeghers Syndrome Small Bowel Polyp | Procedure: Cold snare polypectomy | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Estimated Study Start Date : | August 20, 2023 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | February 1, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Peutz-Jeghers syndrome
| 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 |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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.
- Incidence of complications within 28 days after enteroscopy [ Time Frame: 28 days after the procedure ]Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.
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| Ages Eligible for Study: | 8 Years to 60 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001476
Locations
| China, Shandong | |
| Qilu Hospital, Shandong University | |
| Jinan, Shandong, China, 250012 | |
Sponsors and Collaborators
Shandong University
Publications:
| Responsible Party: | Xiuli Zuo, Director of Qilu Hospital gastroenterology department, Shandong University |
| ClinicalTrials.gov Identifier: | NCT06001476 |
| Other Study ID Numbers: |
2023-SDU-QILU-G002 |
| First Posted: | August 21, 2023 Key Record Dates |
| Last Update Posted: | August 21, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Peutz-Jeghers Syndrome Syndrome Polyps Intestinal Polyps Disease Pathologic Processes Pathological Conditions, Anatomical Neoplastic Syndromes, Hereditary Neoplasms Intestinal Polyposis |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Genetic Diseases, Inborn Lentigo Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases |