Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Gastrointestinal Neoplasm Clinical Trial

Official title:

Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06134687
• Other study ID #: H-53924
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Baylor College of Medicine
• Contact: Michael Mercado, BS
• Phone: 713-798-3606
• Email: Michael.Mercado[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this prospective, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD.

The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.

Description:

Endoscopic submucosal dissection (ESD) is preferred resection method for advanced colonic polyp due to its higher rates of en bloc and R0 resection which lead to higher curative resection rate.1 In comparison to gastric ESD, colonic ESD is more challenging due to colonic unique anatomy and configuration. Tumor of size ≥ 50 mm, spreading across ≥ two folds, flexure locations have been described as strong predictors for difficulties during colonic ESD.2 Redundant colon and looping during colonoscopy may preclude successful advancement of the colonoscope and maintaining stable position for complex polyp removal.

Historically, various methods have been applied to facilitate colonoscopy and scope advancement in challenging positions and redundant colonic loops such as application of external pressure, exchange to pediatric colonoscope, torque-based reduction maneuvers, and patient repositioning. However, despite these, scope tip stabilization could potentially remain as a challenging and limiting factor for procedure progress and could lead to a longer procedure time, sedation time and perhaps lower procedure success rate. In comparison overtube-assisted colonoscopy allows for straightening of the colon to decrease angulation and loop formation.3 Several variations of overtubes have been put to use in the last few decades with comparable results such as single-balloon and double-balloon enteroscope, spiral overtube-assisted colonoscopy and double-balloon platform (DiLumenTM). DiLumen system consists of a plastic sheet fitting layer with two balloon few inches from each other in the tip of the device facilitating the scope tip stability. Most recently the efficacy of DiLumen platform were evaluated in a multicenter study including 162 patients who underwent endoscopic resection of advanced polyps.4 In this study technical success was achieved in 92% of patients without any device related adverse event. 4 In this study using an overtube resulted in faster and more efficient dissection.4 In a retrospective study of 88 polyps located within the proximal colon, ESD with assistance of traditional single balloon overtube resulted in significantly less perforation rate in polyps ≥ 40mm in the proximal colon, despite overall similar en bloc and R0 resection rates comparison to conventional ESD.5 Most recently, a novel dynamic rigidizing overtube (Pathfinder, Neptune Medical, Burlingame, Calif, USA) has been introduced to face the challenges encountered during difficult colonoscopies and to ensure scope stabilization during endoscopic mucosal resection (EMR) and ESD. The overtube material is soft and pliable on flexible state, however when the vacuum is applied the entire tube becomes 15 times stiffer.6 This unique feature of the device provides scope flexibility during colonoscope introduction and entire device stability when rigidizing system is applied.

Our team collected preliminary prospective data of 58 polyps removed by EMR (24.1%) and ESD (75.9% ) with the assistance off rigidizing overtube. Technical success (ability to complete the entire resection using the device) and clinical success (ability of endoscopic removal of polyps without changing the initial resection intent) was achieved 100% and 90% of the time, respectively. On endoscopist feedback, the rigidizing overtube was though to assist in resection in 98.3% of polyps, although the polyp was located in a somewhat/very difficult location 81% of the time. For polyps in difficult locations, the rigidizing overtube was able to maintain scope position without falling back even once, 55% of the time. This result was presented at the most recent Digestive Disease Week conference in Chicago 2023 (p1932).

As this device has been put to use recently in the United States, published literature to demonstrate its safety and efficacy in colonic ESD is lacking. The main aim of this study is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame CA, USA) device in comparison to conventional ESD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: July 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Patient is = 22 years old.

• Patients can provide written 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 proximal to the sigmoid colon.

B - Granular lateral spreading tumors (GLST) more than 30mm. 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 refused and/or unable to provide written informed consent.

• Patient is a pregnant or nursing woman.

• Lesions with morphology: pedunculated type (Paris Ip, Ips).

• Lesions located within the sigmoid colon or rectum.

• Lesions involving appendiceal orifice or ileocecal valve

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms

Intervention

Procedure:
• Endoscopic Submucosal Dissection
Removal of study eligible lesions per endoscopic submucosal dissection

Device:
• Novel Rigidizing Overtube
Utilization of the Novel Rigidizing Overtube (Pathfinder) to aid in performing colonic endoscopic submucosal dissection

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Baylor St. Lukes Medical Center (BSLMC)	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Neptune Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Procedure Time	Total Procedure Time to perform ESD from scope in to scope out	Day 1 (procedure day)
Secondary	Navigation Time	Total time needed to reach the lesion	Day 1 (procedure day)
Secondary	Technical Success	The ability to complete the entire resection using the device without the need to change to a different tool. This will be marked as either 'yes' or 'no' on the collection report form following the procedure by the research team.	Day 1 (procedure day)
Secondary	Clinical Success	The ability of endoscopic removal of polyps without changing the initial resection intent. This will be marked as either 'yes' or 'no' on the collection report form following the procedure by the research team.	Day 1 (procedure day)
Secondary	En-bloc, R0, and curative resection rates	As collected and measured for each group	Day 1 (procedure day)
Secondary	Dissection speed during colonic ESD as calculated by	cm^2/hr	Day 1 (procedure day)
Secondary	Closure time	Time needed to close area following endoscopic resection	Day 1 (procedure day)
Secondary	Sedation time	Total time patient spent under anesthesia	Day 1 (procedure day)
Secondary	User-feedback post-procedure	Subjective assessment of the degree of difficulty reaching the lesion based on a brief questionnaire given to the endoscopist following the procedure.	Day 1 (procedure day)