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

NCT ID: NCT06001476

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2025-02-01

Brief Summary

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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

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Conditions

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Peutz-Jeghers Syndrome Small Bowel Polyp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cold snare polypectomy group

Group Type EXPERIMENTAL

Cold snare polypectomy

Intervention Type PROCEDURE

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

Interventions

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Cold snare polypectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

Director of Qilu Hospital gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

References

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van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23.

Reference Type BACKGROUND
PMID: 31342472 (View on PubMed)

Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.

Reference Type BACKGROUND
PMID: 28212588 (View on PubMed)

Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.

Reference Type BACKGROUND
PMID: 28970290 (View on PubMed)

Sakamoto H, Yamamoto H, Hayashi Y, Yano T, Miyata T, Nishimura N, Shinhata H, Sato H, Sunada K, Sugano K. Nonsurgical management of small-bowel polyps in Peutz-Jeghers syndrome with extensive polypectomy by using double-balloon endoscopy. Gastrointest Endosc. 2011 Aug;74(2):328-33. doi: 10.1016/j.gie.2011.04.001. Epub 2011 Jun 25.

Reference Type BACKGROUND
PMID: 21704992 (View on PubMed)

Wang YX, Bian J, Zhu HY, Dong YH, Fang AQ, Li ZS, Du YQ. The role of double-balloon enteroscopy in reducing the maximum size of polyps in patients with Peutz-Jeghers syndrome: 12-year experience. J Dig Dis. 2019 Aug;20(8):415-420. doi: 10.1111/1751-2980.12784. Epub 2019 Jun 17.

Reference Type BACKGROUND
PMID: 31099986 (View on PubMed)

Sato J, Hirooka Y, Watanabe O, Nakamura M, Yamamura T, Funasaka K, Ohno E, Kawashima H, Miyahara R, Goto H. Newly Developed Endoscopic Treatment for Small Bowel Polyps: Cold Snare Polypectomy. Intern Med. 2016;55(18):2601-3. doi: 10.2169/internalmedicine.55.6732. Epub 2016 Sep 15.

Reference Type BACKGROUND
PMID: 27629953 (View on PubMed)

Hamada K, Takeuchi Y, Ishikawa H, Tonai Y, Matsuura N, Ezoe Y, Ishihara R, Tomita Y, Iishi H. Feasibility of Cold Snare Polypectomy for Multiple Duodenal Adenomas in Patients with Familial Adenomatous Polyposis: A Pilot Study. Dig Dis Sci. 2016 Sep;61(9):2755-9. doi: 10.1007/s10620-016-4165-7. Epub 2016 Apr 28. No abstract available.

Reference Type BACKGROUND
PMID: 27126203 (View on PubMed)

Maruoka D, Matsumura T, Kasamatsu S, Ishigami H, Taida T, Okimoto K, Nakagawa T, Katsuno T, Arai M. Cold polypectomy for duodenal adenomas: a prospective clinical trial. Endoscopy. 2017 Aug;49(8):776-783. doi: 10.1055/s-0043-107028. Epub 2017 May 10.

Reference Type BACKGROUND
PMID: 28493238 (View on PubMed)

Other Identifiers

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2023-SDU-QILU-G002

Identifier Type: -

Identifier Source: org_study_id

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