Traction vs. No Traction in Colonic ESD

NCT ID: NCT06159634

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2026-06-30

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.

Detailed Description

Endoscopic submucosal dissection (ESD) is the mainstay for the treatment of complex colorectal polyps particularly those with a higher risk of superficial submucosal invasion. However, colonic ESD is technically difficult given the thin colon wall and difficult locations of lesion. Endoscopic submucosal dissection (ESD) of colonic lesions can be difficult because the thins wall of the colon wall and the lack of submucosal space expansion to the degree seen in the submucosal dissection in the esophagus or the stomach. ESD can be done in a standard fashion with circumferential incision followed by submucosal dissection according to gravity, tunneling methods, pocket methods or traction. Traction is frequently used to expedite submucosal dissection in particularly in tough locations or in fibrotic lesions. Traction assisted ESD is particularly attractive in colonic ESD given the above-mentioned difficulties and the challenge with performing other techniques such as tunneling or pocket formation in fibrotic lesions or lesions over folds. Tissue traction can be applied by several methods including gravity, mucosal tension, water pressure, and adjusting the patient's body position. Traction can also be applied using devices such as clip and line, snare or using additional endoscope. Data regarding the value of traction in colonic ESD is controversial. Despite multiple publications about the efficacy of traction devices in the east, there are few published data from the west. The Sure trac system was recently approved in the US for traction assisted ESD. The system has 2 devices, the primary device comes preloaded with a silicone band, while the secondary device features a clip of the same size as the primary device to apply traction on the opposite wall. Traction with sure trac system, is readily assembled and easily accessible and it is equipped with its own clip for swift implementation, thus expediting the process. The purpose of this research is to compare the effectiveness and safety of the sure trac traction system (Micro Tec endoscopy, USA) to standard ESD without applying traction.

Conditions

Gastrointestinal Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ESD with traction device

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

Group Type: EXPERIMENTAL

Endoscopic Submucosal Dissection

Intervention Type: PROCEDURE

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

Traction Device

Intervention Type: DEVICE

Use of traction device to aid in removing target lesions

Control arm

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

Group Type: ACTIVE_COMPARATOR

Endoscopic Submucosal Dissection

Intervention Type: PROCEDURE

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

Interventions

Endoscopic Submucosal Dissection

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

Intervention Type: PROCEDURE

Traction Device

Use of traction device to aid in removing target lesions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is ≥ 18 years old.

2. Patients can provide informed consent.

3. 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.

Exclusion Criteria

1. Patient is < 18 years old.

2. Patient refused and/or unable to provide consent.

3. Patient is a pregnant woman.

4. Lesions with morphology: pedunculated type (Paris IP, Ips).

5. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Micro-Tech Endoscopy USA

UNKNOWN

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Othman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Othman, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mai Khalaf, MD

Role: CONTACT

Mai.Khalaf@bcm.edu

713-798-6696

Michael Mercado, BS

Role: CONTACT

Michael.Mercado@bcm.edu

713-798-3606

Facility Contacts

Mohamed O. Othman, MD

Role: primary

Mohamed.Othman@bcm.edu

713-798-0950

Mohamed O. Othman, MD

Role: primary

Mohamed.Othman@bcm.edu

713-798-0950

Michael Mercado

Role: backup

Michael.Mercado@bcm.edu

7137983606

References

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Reference Type: BACKGROUND

PMID: 22533757 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33738368 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36191269 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29242059 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26793785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27464708 (View on PubMed)

Other Identifiers

H-53522

Identifier Type: -

Identifier Source: org_study_id