Hybrid Versus Non-Hybrid Endoscopic Submucosal Dissection for Colorectal Polyps (SHORT-ESD)

NCT05347446 | Completed DMC

• 1 other identifier: 1880189
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 5

Brief Summary

This proposed trial will randomize 60 patients with a ≥20 mm large colorectal polyp to either undergo hybrid or non-hybrid ESD. For the primary comparison (hybrid vs non-hybrid ESD), the primary outcome will be procedure time. The study will further examine the safety and efficacy of hybrid ESD compared to non-hybrid ESD and investigate factors that may be associated with resection outcomes.

Conditions

Colorectal Lesions

Outcome Measures

Primary Outcomes (1)

• • The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD.

  The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD. Procedure time is defined as the time from the beginning of the submucosal injection to completion of the ESD, defined as complete removal of the polyp from the colonic wall and all interventions for any intraprocedural adverse events. Procedure speed will be calculated by diving the area of the resected specimen by the procedure time (cm2/minute). The following formula will be used to calculate the area: π (3.14) x 0.25 x long axis x short axis/procedure time.

  1 day

Secondary Outcomes (7)

• En-Bloc resection rate

  1 day

• Completeness of resection

  1 day

• Complete (R0) resection rate

  1 day

• Polyp recurrence

  6 months

• Incidence of overall severe adverse events

  6 months

Study Arms (2)

Hybrid ESD

ACTIVE COMPARATOR

Hybrid ESD is a modified ESD technique that uses snare-assisted resection as part of the procedure. With hybrid ESD, a circumferential mucosal incision followed by limited submucosal dissection is performed. Following this, a snare is placed around the lesion, slowly closed to allow resection by traversing the submucosal space

Procedure: Hybrid ESD

Non-Hybrid ESD

ACTIVE COMPARATOR

A partial or complete circumferential mucosal incision will be performed to expose the submucosa around and underneath the polyp. Endoscopic resection will then proceed via conventional ESD, submucosal tunneling or pocket technique.

Procedure: Non-hybrid ESD

Interventions

Hybrid ESD PROCEDURE

Method of removing colon lesion

Also known as: Endoscopic Mucosal Resection

Hybrid ESD

Non-hybrid ESD PROCEDURE

Method of removing colon lesion

Also known as: Endoscopic Mucosal Resection

Non-Hybrid ESD

Eligibility Criteria

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

You may qualify if:

• Any patient ≥18 years
• Ability to provide informed consent
• Patient scheduled to undergo colonoscopy with endoscopic resection of colorectal polyps
• Non-pedunculated polyps measuring ≥20 mm in lateral diameter by endoscopic estimation

You may not qualify if:

• Age \< 18 years
• Inability to provide informed consent
• Pedunculated polyps (as defined by Paris classification type Ip)8
• Lesions \< 20 mm in lateral diameter
• Suspected adenocarcinoma with deep submucosal invasion (e.g. Paris III morphology, Kudo type Vn pit pattern)4,13
• Previously attempted incomplete endoscopic resection (EMR) of the lesion
• Uncorrected coagulopathy defined as an elevated INR ≥ 1.5 and/or platelet count \< 50,000
• Any standard contraindication to anesthesia and/or colonoscopy
• Pregnancy or lactating women

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (5)

University of Florida

Gainesville, Florida, 32611, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Parkview

Fort Wayne, Indiana, 46845, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (27)

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• Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Kudo SE, Tsuruta O, Sugihara KI, Watanabe T, Saitoh Y, Igarashi M, Toyonaga T, Ajioka Y, Ichinose M, Matsui T, Sugita A, Sugano K, Fujimoto K, Tajiri H. JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2015 May;27(4):417-434. doi: 10.1111/den.12456. Epub 2015 Mar 5.

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• Draganov PV, Wang AY, Othman MO, Fukami N. AGA Institute Clinical Practice Update: Endoscopic Submucosal Dissection in the United States. Clin Gastroenterol Hepatol. 2019 Jan;17(1):16-25.e1. doi: 10.1016/j.cgh.2018.07.041. Epub 2018 Aug 2.

  PMID: 30077787 RESULT

• Fuccio L, Hassan C, Ponchon T, Mandolesi D, Farioli A, Cucchetti A, Frazzoni L, Bhandari P, Bellisario C, Bazzoli F, Repici A. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Jul;86(1):74-86.e17. doi: 10.1016/j.gie.2017.02.024. Epub 2017 Feb 28.

  PMID: 28254526 RESULT

• McCarty TR, Bazarbashi AN, Thompson CC, Aihara H. Hybrid endoscopic submucosal dissection (ESD) compared with conventional ESD for colorectal lesions: a systematic review and meta-analysis. Endoscopy. 2021 Oct;53(10):1048-1058. doi: 10.1055/a-1266-1855. Epub 2020 Dec 16.

  PMID: 32947624 RESULT

• The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc. 2003 Dec;58(6 Suppl):S3-43. doi: 10.1016/s0016-5107(03)02159-x. No abstract available.

  PMID: 14652541 RESULT

• Yang D, Draganov PV. Gaining traction: pulley-ing your weight during endoscopic submucosal dissection. Gastrointest Endosc. 2019 Jan;89(1):185-187. doi: 10.1016/j.gie.2018.09.021. No abstract available.

  PMID: 30567675 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

• Iwasa T, Nakadate R, Onogi S, Okamoto Y, Arata J, Oguri S, Ogino H, Ihara E, Ohuchida K, Akahoshi T, Ikeda T, Ogawa Y, Hashizume M. A new robotic-assisted flexible endoscope with single-hand control: endoscopic submucosal dissection in the ex vivo porcine stomach. Surg Endosc. 2018 Jul;32(7):3386-3392. doi: 10.1007/s00464-018-6188-y. Epub 2018 Apr 17.

  PMID: 29667042 RESULT

• Turiani Hourneaux de Moura D, Aihara H, Jirapinyo P, Farias G, Hathorn KE, Bazarbashi A, Sachdev A, Thompson CC. Robot-assisted endoscopic submucosal dissection versus conventional ESD for colorectal lesions: outcomes of a randomized pilot study in endoscopists without prior ESD experience (with video). Gastrointest Endosc. 2019 Aug;90(2):290-298. doi: 10.1016/j.gie.2019.03.016. Epub 2019 Mar 25.

  PMID: 30922861 RESULT

• Kudo S, Rubio CA, Teixeira CR, Kashida H, Kogure E. Pit pattern in colorectal neoplasia: endoscopic magnifying view. Endoscopy. 2001 Apr;33(4):367-73. doi: 10.1055/s-2004-826104. No abstract available.

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• ASGE Standards of Practice Committee; Acosta RD, Abraham NS, Chandrasekhara V, Chathadi KV, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Shergill AK, Wang A, Cash BD, DeWitt JM. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016 Jan;83(1):3-16. doi: 10.1016/j.gie.2015.09.035. Epub 2015 Nov 24. No abstract available.

  PMID: 26621548 RESULT

• Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.

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• Saito Y, Abe S, Inoue H, Tajiri H. How to Perform a High-Quality Endoscopic Submucosal Dissection. Gastroenterology. 2021 Aug;161(2):405-410. doi: 10.1053/j.gastro.2021.05.051. Epub 2021 Jun 2. No abstract available.

  PMID: 34089735 RESULT

• Draganov PV, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Westerveld D, Perbtani YB, Hoffman BJ, Schlachterman A, Siegel A, Coman RM, Wang AY, Yang D. Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study. Gastroenterology. 2021 Jun;160(7):2317-2327.e2. doi: 10.1053/j.gastro.2021.02.036. Epub 2021 Feb 19.

  PMID: 33610532 RESULT

• Bae JH, Yang DH, Lee S, Soh JS, Lee S, Lee HS, Lee HJ, Park SH, Kim KJ, Ye BD, Myung SJ, Yang SK, Byeon JS. Optimized hybrid endoscopic submucosal dissection for colorectal tumors: a randomized controlled trial. Gastrointest Endosc. 2016 Mar;83(3):584-92. doi: 10.1016/j.gie.2015.06.057. Epub 2015 Aug 28.

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• Takezawa T, Hayashi Y, Shinozaki S, Sagara Y, Okada M, Kobayashi Y, Sakamoto H, Miura Y, Sunada K, Lefor AK, Yamamoto H. The pocket-creation method facilitates colonic endoscopic submucosal dissection (with video). Gastrointest Endosc. 2019 May;89(5):1045-1053. doi: 10.1016/j.gie.2019.01.022. Epub 2019 Feb 1.

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• Klein A, Bourke MJ. How to Perform High-Quality Endoscopic Mucosal Resection During Colonoscopy. Gastroenterology. 2017 Feb;152(3):466-471. doi: 10.1053/j.gastro.2016.12.029. Epub 2017 Jan 3. No abstract available.

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• 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.

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• Wang AY, Hwang JH, Bhatt A, Draganov PV. AGA Clinical Practice Update on Surveillance After Pathologically Curative Endoscopic Submucosal Dissection of Early Gastrointestinal Neoplasia in the United States: Commentary. Gastroenterology. 2021 Dec;161(6):2030-2040.e1. doi: 10.1053/j.gastro.2021.08.058. Epub 2021 Oct 21.

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  RESULT

• Yang D, Hasan MK, Jawaid S, Singh G, Xiao Y, Khalaf M, Tomizawa Y, Sharma NS, Draganov PV, Othman MO. Hybrid Versus Conventional Colorectal Endoscopic Submucosal Dissection: A Multicenter Randomized Controlled Trial (Short-Endoscopic Submucosal Dissection). Am J Gastroenterol. 2024 Dec 1;119(12):2436-2443. doi: 10.14309/ajg.0000000000002897. Epub 2024 Jun 24.

  PMID: 38912697 DERIVED

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Dennis Yang, MD

  AdventHealth Orlando

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Once the subject is consented and enrolled after intraprocedural confirmation of inclusion and exclusion criteria, the randomization envelope will be opened to assign the subject to either Hybrid ESD or Non-Hybrid ESD.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized trial where the subject will either be randomized to Hybrid Endoscopic Submucosal Dissection or Non-Hybrid Endoscopic Submucosal Dissection. The provider nor the participant will be aware of what group the subject will be randomized to.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: May 9, 2022
• Primary Completion: January 17, 2024
• Study Completion: December 19, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)