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Peutz-Jeghers SyndromePhase 4NCT06001476

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

A Phase 4 study testing Cold snare polypectomy in people with Peutz-Jeghers Syndrome and Small Bowel Polyp, run by Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 60 years
Conditions the study is for
Peutz-Jeghers Syndrome, Small Bowel Polyp
What is being tested?
Cold snare polypectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
20 Aug 2023to 1 Feb 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qilu Hospital, Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

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

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.

Being tested
Cold snare polypectomy
Medical subject headings
Peutz-Jeghers Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold snare polypectomyProcedure or surgery

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

Study groups in NCT06001476
Study groupRoleWhat they receive
Cold snare polypectomy groupExperimentalNot described
Receives: Procedure: Cold snare polypectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS

    The complications include complications during CSP and complications occurring within 28 days after enteroscopy

    Measured: 28 days after the procedure

Secondary outcomes (2)

  1. Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy

    Including intraoperative bleeding (defined as active haemorrhage for more than 30s), perforation immediately, etc.

    Measured: Immediately after the procedure

  2. Incidence of complications within 28 days after enteroscopy

    Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.

    Measured: 28 days after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start20 Aug 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001476
Sponsor's protocol ID
2023-SDU-QILU-G002
Status last verified
Aug 2023
First submitted
14 Aug 2023
Last updated
21 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31342472

  • 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.

    PubMed 28212588

  • 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.

    PubMed 28970290

  • 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.

    PubMed 21704992

  • 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.

    PubMed 31099986

  • 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.

    PubMed 27629953

  • 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.

    PubMed 27126203

  • 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.

    PubMed 28493238

  • Zeng S, Liu J, Li Y, Wang L, Yu Y, Ji R, Guo J, Zuo XL. Cold Snare Polypectomy for 5-9 mm Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome by Double-Balloon Enteroscopy: A Prospective Clinical Trial. Am J Gastroenterol. 2026 Aug 3. doi: 10.14309/ajg.0000000000004176. Online ahead of print. No abstract available.

    PubMed 42544942

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cold snare polypectomy in people with Peutz-Jeghers Syndrome and Small Bowel Polyp, run by Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06001476, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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