UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study investigating the efficacy and safety of cold snarepolypectomy for pedunculated polyp (0-Ip polyp)
Acronym	Efficacy and safety of cold snare polypectomy for pedunculated polyp (0-Ip polyp)
Scientific Title	Feasibility study investigating the efficacy and safety of cold snarepolypectomy for pedunculated polyp (0-Ip polyp)
Scientific Title:Acronym	Efficacy and safety of cold snare polypectomy for pedunculated polyp (0-Ip polyp)
Region	Japan

Condition
Condition	Colorectal polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of cold snare polypectomy for colorectal pedunculated polyp (0-Ip polyp)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of delayed bleeding
Key secondary outcomes	The rate of immediate bleeding The rate of perforation The retrieval rate of the resected spiecemen The pathological margin of the spiecemen The rate of en bloc resection The rate of curative resection The rate of requiring additional electrocautery The thickness of stalk procedure time

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with colorectal polyps were consequentially enrolled in the present study.
Key exclusion criteria	Patients whose lesions were found to be outside the guideline or expanded criteria for CSP by the endoscopic characteristics. When the thickness of the stalk is thicker than the sheath of the snare Patients in disagreement with informed consent
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Arimoto
Organization	Omori Red Cross Hospital
Division name	Department of Gastroenterology
Zip code	143-8527
Address	4-30-1, Ohta-ku, Chuo, Tokyo
TEL	0337753111
Email	junarimoto_junjun@yahoo.co.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Arimoto
Organization	Omori Red Cross Hospital
Division name	Department of Gastroenterology
Zip code	143-8527
Address	4-30-1, Ohta-ku, Chuo, Tokyo
TEL	0337753111
Homepage URL
Email	junarimoto_junjun@yahoo.co.jp

Sponsor
Institute	Omori Red Cross Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization	This study do not need financial support
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Omori Red Cross Hospital
Address	4-30-1, Ohta-ku, Chuo, Tokyo
Tel	03-3775-3111
Email	junarimoto_junjun@yahoo.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 27 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/34727817/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/
Number of participants that the trial has enrolled	89
Results	The en-bloc resection rate was 100%. The rate of DPPB after CSP was 0%, however, DPPB after conversion to HSP occurred in 1 case (33.3% (1/3)).
Results date posted	2022 Year 01 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The total number of patients was 89, with a mean age of 70.5 years. In all, 15 patients were receiving antithrombotic therapy
Participant flow	During the study period, 89 consecutive patients were prospectively enrolled.
Adverse events	There was no case of perforation. The rate of immediate bleeding during CSP was 28.9% (33/114), and all cases of immediate bleeding could be adequately controlled by hemostasis clipping. The rate of DPPB after CSP was 0%; however, DPPB after conversion to HSP occurred in 1 case (33.3% (1/3)).
Outcome measures	The primary outcome measure was the incidence of bleeding (DPPB and immediate bleeding).The rate of DPPB after CSP was 0%. The rate of immediate bleeding during CSP was 28.9%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 01 Month 16 Day
Date of IRB	2018 Year 12 Month 20 Day
Anticipated trial start date	2019 Year 01 Month 27 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 01 Month 31 Day
Date analysis concluded	2020 Year 02 Month 27 Day

Other
Other related information	Observational study about usefulness and safety of CSP for pedunculated polyp (0-Ip polyp) This is a single arm study. The target lesion is adaptive lesion for CSP

Management information
Registered date	2019 Year 01 Month 27 Day
Last modified on	2022 Year 01 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040465