A study comparing the effects of two polyp removal methods (hot snare polypectomy [using electrocautery] vs cold snare polypectomy [without electrocautery]) on suppressing polyp development in patients with familial adenomatous polyposis (FAP).

A split-body prospective comparative study of tumor-suppressive effects of hot snare polypectomy versus cold snare polypectomy in patients with familial adenomatous polyposis - FAP HSPvsCSP Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061118

Enrollment

Registered

2026-03-31

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

familial adenomatous polyposis

Interventions

Hot snare polypectomy (HSP) Intensive downstaging polypectomy (IDP) using hot snare polypectomy with electrocautery is performed in one of the lower rectal areas allocated by 1:1 randomization. The s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 18 years or older at the time of consent 2. Individuals diagnosed with familial adenomatous polyposis (FAP) based on clinical or genetic diagnosis 3. Individuals who have not undergone surgical resection of the lower rectum 4. Individuals in good general condition (ASA physical status I-II) and judged able to safely undergo endoscopic treatment 5. Individuals able to undergo regular follow-up as an outpatient or inpatient

Exclusion criteria

Exclusion criteria: 1. Dense-type FAP, defined as a phenotype with diffusely dense distribution of 1000 or more adenomatous polyps in the colorectum 2. Individuals with severe bleeding disorders or an extremely high bleeding risk, such as those receiving anticoagulant therapy that cannot be discontinued 3. Pregnant or breastfeeding women 4. Individuals judged inappropriate for participation in this study by the principal investigator or subinvestigators

Design outcomes

Primary

Measure	Time frame
The number of tumors resected at 24 months after the initial treatment in each predefined lower rectal area treated with CSP or HSP.	—

Secondary

Measure	Time frame
1.The number of lesions pathologically diagnosed as adenoma or carcinoma among the lesions resected at 24 months after the initial treatment 2.The number of adenomas measuring 10 mm or larger and the number of rectal cancers identified at 24 months after the initial treatment 3.The incidence of treatment-related adverse events during and after treatment, including immediate bleeding, delayed bleeding, and post-polypectomy coagulation syndrome (PPCS) 4.Procedure time at the initial treatment and at the 6-month treatment session	—

Measure

Time frame

1.The number of lesions pathologically diagnosed as adenoma or carcinoma among the lesions resected at 24 months after the initial treatment 2.The number of adenomas measuring 10 mm or larger and the number of rectal cancers identified at 24 months after the initial treatment 3.The incidence of treatment-related adverse events during and after treatment, including immediate bleeding, delayed bleeding, and post-polypectomy coagulation syndrome (PPCS) 4.Procedure time at the initial treatment and at the 6-month treatment session

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Countries

Japan

Contacts

Public ContactHidenori Tanaka

Hiroshima University Hospital Department of Gastroenterology

hitanaka@hiroshima-u.ac.jp082-257-5193

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026