Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps (HSPvsHSPASI)

April 6, 2020 updated by: Bo-In Lee

Hot Snare Polypectomy Vs. Hot Snare Polypectomy After Saline Injection for the Complete Resection of Neoplastic Colorectal Polyps: Prospective, Randomized Controlled Trial

The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • Division of Gastroenterology; Seoul St. Mary's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over the age of 30
  • 5~10mm sized colorectal polyps
  • Informed consent

Exclusion Criteria:

  • Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
  • Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
  • ASA class III or more
  • Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hot snare polypectomy
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
Procedure: hot snare polypectomy
hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
Experimental: Hot snare polypectomy(saline injection)
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
Procedure: hot snare polypectomy after saline injection
hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Resection Rate
Time Frame: 2 weeks after
Complete resection was defined as the absence of residual polyp in the resection margin
2 weeks after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral Margin
Time Frame: 2 weeks after
Observation of maring on a recsected specimen
2 weeks after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bo-In Lee

Collaborators

St Vincent's Hospital
Incheon St.Mary's Hospital

Investigators

  • Principal Investigator: Bo-In Lee, Seoul st. mary's hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC14TIMI0039K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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