Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD

NCT06747988 | Not Yet Recruiting

• 1 other identifier: H-56820
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Technical success

  Being able to dissect the lesion to facilitate en bloc removal (removal of the entire tumor endoscopically in one piece)

  Day 1 (procedure day)

Secondary Outcomes (7)

• Dissection speed

  Day 1 (procedure day)

• R0 and curative resection rates

  Day 1 (procedure day)

• Total procedure time

  Day 1 (procedure day)

• NASA Task Load Index

  Day 1 (procedure day)

• Intraprocedural adverse events

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

Interventions

Traction Device DEVICE

After circumferential incision and trimming the submucosa at the incision's edge, dissection is initiated until approximately 20 to 30% of the anal side (for colonic lesions) or oral side (for gastric lesions) of lesion has been dissected leaving a flap of at least 1 cm in length. Once the mucosal flap is created the X-tack device is introduced through the endoscope channel. The first tack is placed on the opposite wall of the lesion, the 2nd and 3rd tack will then be placed next to each other on the mucosal flap portion of the lesion. The 4th tack does not have to be placed but can be used to generate further traction at any time. Clips can be placed along the suture and clipped to the wall at any point to change angulation of traction. The sutures can then be cut and released from the tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ESD procedure at Baylor St. Luke's Medical Center - Houston, TX.

You may qualify if:

• The patient is ≥ 18 years old.
• Patients can provide informed consent.
• The patient is referred for ESD procedure of colonic or gastric neoplastic lesions and with one of the following criteria:
• A- Lesions with prior failed resection of any size. B- Granular lateral spreading tumors (GLST) more than 30 mm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any lesion with suspected superficial submucosal invasion. E- Subepithelial lesions.

You may not qualify if:

• The patient is \< 18 years old.
• The patient refuses and/or is unable to provide consent.
• The patient is a pregnant woman.
• Lesions with morphology: pedunculated type (Paris Ip, Ips).
• Appendiceal orifice or IC valve lesions
• Patients with lesions removed with other techniques besides ESD (submucosal tunneling technique \[STER\] or EMR).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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: 22533757 RESULT

• 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: 33738368 RESULT

• 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: 29242059 RESULT

• Hernandez A, Marya NB, Sawas T, Rajan E, Gades NM, Wong Kee Song LM, Abu Dayyeh BK, Buttar N, Storm AC. Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video). Endosc Int Open. 2021 Apr;9(4):E572-E577. doi: 10.1055/a-1370-9256. Epub 2021 Apr 12.

  PMID: 33860074 RESULT

• Ge PS, Thompson CC, Jirapinyo P, Aihara H. Suture pulley countertraction method reduces procedure time and technical demand of endoscopic submucosal dissection among novice endoscopists learning endoscopic submucosal dissection: a prospective randomized ex vivo study. Gastrointest Endosc. 2019 Jan;89(1):177-184. doi: 10.1016/j.gie.2018.08.032. Epub 2018 Aug 25.

  PMID: 30148993 RESULT

• Rieder E, Makris KI, Martinec DV, Swanstrom LL. The suture-pulley method for endolumenal triangulation in endoscopic submucosal dissection. Endoscopy. 2011;43 Suppl 2 UCTN:E319-20. doi: 10.1055/s-0030-1256774. Epub 2011 Oct 21. No abstract available.

  PMID: 22020705 RESULT

• 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: 27464708 RESULT

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Medicine

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 24, 2024
• Study Start: March 30, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)