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NCT Number: NCT06159634

Traction vs. No Traction in Colonic ESD

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Endoscopic submucosal dissection

Procedure

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

Traction Device

Device

Use of traction device to aid in removing target lesions

Primary outcomes

  1. Dissection speed

    Time frame: Day 1 (procedure day)

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

Secondary outcomes

  1. En-bloc, R0, and curative resection rates

    Time frame: Day 1 (procedure day)

    As collected for each group

  2. Total procedure time

    Time frame: Day 1 (procedure day)

    Total procedure time to perform ESD from scope in to scope out

  3. Intraprocedural adverse events

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

    Such as muscularis propria injury and bleeding (related to or not related to the traction devices).

  4. Post-procedural adverse events

    Time frame: 1 month post-procedure

    As reported per subject follow-ups with the patient within 1 month.

  5. Abdominal pain

    Time frame: 1 hour post-procedure, 24 hours post-procedure.

    Collected at 1 hour and 24 hours after procedure utilizing the Visual analogue scale (VAS)

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Khalaf, MD

CONTACT

[email protected]

713-798-6696

Michael Mercado, BS

CONTACT

[email protected]

713-798-3606

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Micro-Tech Endoscopy USA

Registry information

Official study title

Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 7, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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