A Randomized Comparison of UnderwateR Versus Regular Coagulation in Endoscopic Submucosal DissectioN and Third Space Endoscopy

NCT05804266 | Completed

• 1 other identifier: CURRENT ID 3303
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

What the investigatorpropose in this protocol is a technique already used in clinical practice. It prevents the risk of bleeding and make third space endoscopy easier, quicker, safer and cheaper. Indeed, we noticed that preventive underwater coagulation of the candidate vessels during the submucosal dissection with the Hybrid Knife (HK), seal the wall of the vessel, resulting in a subsequent cut under CO2 without any bleeding. Such preventive coagulation is likely to be related with the conduction of the current underwater as it focalizes all the power on the interface between the vessel and the water, allowing a soft sealing of the vessel without cutting it. Despite widely used, there is no evidence up to know on the benefit and harm of such coagulation technique. The hypothesis is that the use of this approach in clinical practice, especially when used to coagulate a vessel, may lead to an increase in safety, feasibility and cost-effectiveness, reducing the procedural time, the rate of complications and the need for coagulation forceps in comparison with the conventional preventive coagulation technique under CO2 insufflation. Therefore, this randomized study compares the underwater coagulation technique with the conventional coagulation technique in the CO2 setting during the submucosal dissection in third space endoscopy.

Conditions

Gastrointestinal Diseases; Endoscopic Surgery

Keywords

POEM, TSE, G-POEM, Z-POEM, PREM

Outcome Measures

Primary Outcomes (1)

• Bleeding

  Rate of patients with at least on vessel bleeding and requiring an adjunctive hemostasis

  12 months

Secondary Outcomes (7)

• delayed bleeding

  12 months

• instrument exchanges

  12 months

• complications rate

  12 months

• Procedural time

  12 months

• Patient-reported outcomes

  12 months

Study Arms (2)

Conventional coagulation of vessels

ACTIVE COMPARATOR

during study procedure accomplished under CO2-insufflation with the HK using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD

Procedure: Coventional coagulation

Underwater coagulation of vessels

EXPERIMENTAL

during study procedure carried out in the underwater setting with the HK using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD

Procedure: Underwater coagulation

Interventions

Coventional coagulation PROCEDURE

In the conventional group, the haemostasis of vessels will be performed with the conventional coagulation technique under CO2 insufflation. First, submucosal fibres surrounding a blood vessel will be dissected and the vessel will be isolated. After, both sides of the isolated vessel will be coagulated using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD until the blood vessel turns white and can be finally cut.

Conventional coagulation of vessels

Underwater coagulation PROCEDURE

In the treatment group, the prophylactic haemostasis of vessels will be accomplished by the underwater coagulation technique. First, physiological solution will be instilled until there is no more air around the blood vessel. Then, the vessel will be coagulated using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD until it turns white and, after the removal of all the physiological solution, can be finally cut.

Underwater coagulation of vessels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All \>18 years-old patients undergoing ESD for superificial GI neoplastic lesions or POEM for esophageal achalasia

You may not qualify if:

• patients on antithrombotic/anticoagulant therapy patients suffering from bleeding disorders patients with esophageal and/or gastric varices patients previously treated for the same reason patients who were not able or refused to give informed written consent. vessels smaller than the knife inner diameter (1.2 mm)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Milan, Italy, 20089, Italy

Location

Related Publications (9)

• Inoue H, Navarro MJH, Shimamura Y, Tanabe M, Toshimori A. The Journey from Endoscopic Submucosal Dissection to Third Space Endoscopy. Gastrointest Endosc Clin N Am. 2023 Jan;33(1):1-6. doi: 10.1016/j.giec.2022.09.004. Epub 2022 Oct 23.

  PMID: 36375876 BACKGROUND

• Maydeo A, Dhir V. Third-space endoscopy: stretching the limits. Gastrointest Endosc. 2017 Apr;85(4):728-729. doi: 10.1016/j.gie.2016.12.002. No abstract available.

  PMID: 28317688 BACKGROUND

• Karanfilian B, Kahaleh M. New Applications for Submucosal Tunneling in Third Space Endoscopy: A Comprehensive Review. J Clin Gastroenterol. 2022 Jul 1;56(6):465-477. doi: 10.1097/MCG.0000000000001694. Epub 2022 Apr 1.

  PMID: 35357336 BACKGROUND

• Bapaye A, Korrapati SK, Dharamsi S, Dubale N. Third Space Endoscopy: Lessons Learnt From a Decade of Submucosal Endoscopy. J Clin Gastroenterol. 2020 Feb;54(2):114-129. doi: 10.1097/MCG.0000000000001296.

  PMID: 31851106 BACKGROUND

• Baars JE, Stoklosa T, Kaffes AJ, Saxena P. Maintaining hemostasis during third-space endoscopy. VideoGIE. 2018 Aug 8;3(10):304-305. doi: 10.1016/j.vgie.2018.07.004. eCollection 2018 Oct. No abstract available.

  PMID: 30276349 BACKGROUND

• Li AA, Zhou MJ, Hwang JH. Understanding the Principles of Electrosurgery for Endoscopic Surgery and Third Space Endoscopy. Gastrointest Endosc Clin N Am. 2023 Jan;33(1):29-40. doi: 10.1016/j.giec.2022.07.001.

  PMID: 36375884 BACKGROUND

• Akintoye E, Kumar N, Obaitan I, Alayo QA, Thompson CC. Peroral endoscopic myotomy: a meta-analysis. Endoscopy. 2016 Dec;48(12):1059-1068. doi: 10.1055/s-0042-114426. Epub 2016 Sep 12.

  PMID: 27617421 BACKGROUND

• Stavropoulos SN, Modayil RJ, Friedel D, Savides T. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc. 2013 Sep;27(9):3322-38. doi: 10.1007/s00464-013-2913-8. Epub 2013 Apr 3.

  PMID: 23549760 BACKGROUND

• Horikawa Y, Toyonaga T, Mizutamari H, Mimori N, Kato Y, Fushimi S, Okubo S. Feasibility of Knife-Coagulated Cut in Gastric Endoscopic Submucosal Dissection: A Case-Control Study. Digestion. 2016;94(4):192-198. doi: 10.1159/000450994. Epub 2016 Dec 9.

  PMID: 27931026 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Considering a mean number of treated vessel of 4 per each patient, with standard technique we expect that 36% of patients need will have at least on vessel bleeding and requiring an adjunctive hemostasis, versus 6% of patients with underwater coagulation technique. With an alpha error of 5%, a power of 80% we need a total of 70 patients (35 in each arm), to detect this difference.

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 7, 2023
• Study Start: April 15, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)