Clinical trial · Interventional
Traction vs. No Traction in Colonic ESD
Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial
NCT06159634CI-TRIAL-00106361recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasm | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Submucosal Dissection | Procedure | — | UNRESOLVED |
| Traction Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ESD with traction device
- description
- ESD of target lesion will be performed with the assistance of a traction device.
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
- Device: Traction Device
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- ESD of target lesion will be performed without the use of a traction device
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
Primary outcomes (1)
- measure
- Dissection speed
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (6)
- BACKGROUNDTanaka 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 22533757
- BACKGROUNDOthman 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 33738368
- BACKGROUNDTamaru 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 36191269
- BACKGROUNDNagata 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 29242059
- BACKGROUNDYamasaki 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 26793785
- BACKGROUNDBurgess 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 27464708