NCT06159634

Brief Summary

The goal of this prospective, randomized, controlled trial conducted at Baylor St. Luke's Medical Center is to compare the effectiveness and clinical outcomes of using a traction device in colonic endoscopic submucosal dissection (ESD) to those of using conventional ESD. The investigators of this study hypothesize that use of the traction device will help expedite colonic endoscopic submucosal dissections.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Dec 2023Feb 2027

First Submitted

Initial submission to the registry

November 27, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

December 5, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

March 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

November 27, 2023

Last Update Submit

March 20, 2026

Conditions

Gastrointestinal Neoplasm

Keywords

Endoscopic Submucosal DissectionEndoscopic Traction

Outcome Measures

Primary Outcomes (1)

  • Dissection speed

    Length of time to perform endoscopic submucosal dissection by the operator as measured by calculating area of lesion divided by time (cm\^2/hours).

    Day 1 (procedure day)

Secondary Outcomes (5)

  • En-bloc, R0, and curative resection rates

    Day 1 (procedure day)

  • Total procedure time

    Day 1 (procedure day)

  • Intraprocedural adverse events

    Day 1 (procedure day), up to 48 hours after procedure.

  • Post-procedural adverse events

    1 month post-procedure

  • Abdominal pain

    1 hour post-procedure, 24 hours post-procedure.

Study Arms (2)

ESD with traction device

EXPERIMENTAL

ESD of target lesion will be performed with the assistance of a traction device.

Procedure: Endoscopic Submucosal DissectionDevice: Traction Device

Control arm

ACTIVE COMPARATOR

ESD of target lesion will be performed without the use of a traction device

Procedure: Endoscopic Submucosal Dissection

Interventions

Endoscopic Submucosal DissectionPROCEDURE

Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.

Control armESD with traction device
Traction DeviceDEVICE

Use of traction device to aid in removing target lesions

ESD with traction device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is ≥ 18 years old.
  • Patients can provide informed consent.
  • Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria:
  • A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

You may not qualify if:

  • Patient is \< 18 years old.
  • Patient refused and/or unable to provide consent.
  • Patient is a pregnant woman.
  • Lesions with morphology: pedunculated type (Paris IP, Ips).
  • Appendiceal orifice or IC valve lesions. 6. Patients with lesions removed with other techniques besides ESD (like hybrid ESD or submucosal tunneling technique STER and EMR).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, 77030, United States

RECRUITING

Related Publications (6)

  • Tanaka S, Terasaki M, Kanao H, Oka S, Chayama K. Current status and future perspectives of endoscopic submucosal dissection for colorectal tumors. Dig Endosc. 2012 May;24 Suppl 1:73-9. doi: 10.1111/j.1443-1661.2012.01252.x.

    PMID: 22533757BACKGROUND

  • Othman MO, Jawaid SA, Rungta M, Sur N, Dhingra S. Double-balloon endolumenal intervention platform with flexible grasper to expedite colonic endoscopic submucosal dissection. VideoGIE. 2020 Dec 26;6(3):144-146. doi: 10.1016/j.vgie.2020.11.014. eCollection 2021 Mar. No abstract available.

    PMID: 33738368BACKGROUND

  • Tamaru Y, Kuwai T, Miyakawa A, Kanazawa N, Kusunoki R, Shimura H, Uchiyama S, Ishaq S, Kohno H. Efficacy of a Traction Device for Endoscopic Submucosal Dissection Using a Scissor-Type Knife: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Nov 1;117(11):1797-1804. doi: 10.14309/ajg.0000000000002019. Epub 2022 Sep 26.

    PMID: 36191269BACKGROUND

  • Nagata M. Usefulness of underwater endoscopic submucosal dissection in saline solution with a monopolar knife for colorectal tumors (with videos). Gastrointest Endosc. 2018 May;87(5):1345-1353. doi: 10.1016/j.gie.2017.11.032. Epub 2017 Dec 12.

    PMID: 29242059BACKGROUND

  • Yamasaki Y, Takeuchi Y, Uedo N, Kato M, Hamada K, Aoi K, Tonai Y, Matsuura N, Kanesaka T, Yamashina T, Akasaka T, Hanaoka N, Higashino K, Ishihara R, Iishi H. Traction-assisted colonic endoscopic submucosal dissection using clip and line: a feasibility study. Endosc Int Open. 2016 Jan;4(1):E51-5. doi: 10.1055/s-0041-107779. Epub 2015 Nov 30.

    PMID: 26793785BACKGROUND

  • Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.

    PMID: 27464708BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Mohamed Othman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mai Khalaf, MD

CONTACT

713-798-6696Mai.Khalaf@bcm.edu

Michael Mercado, BS

CONTACT

713-798-3606Michael.Mercado@bcm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Subjects will be randomized into one of two arms: Conventional ESD, or ESD with traction device
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 7, 2023

Study Start

December 5, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 20, 2027

Last Updated

March 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

There is no expected significant increased risk associated with the use of the traction device in ESD beyond what the current standard is for the procedure. Loss of confidentiality is the only other risk associated with this project. All measures to ensure patient confidentiality will be employed. Data will be coded and entered into a password-protected computer. Only the Principal Investigator and Study Research Coordinators will have access to data with patient identifiers. There will be no disclosure of a patients protected health information. Paper copies of the study documents will be created only as needed and only shown to the investigators listed in the study. Once the study is completed, all paper copies will be destroyed. If the results of the study are published or used in any presentations, all patient related information will be coded.

Locations

US(2)