Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection vs. Endoscopic Submucosal Dissection

NCT06815406 | Recruiting

• 1 other identifier: 104/2021/SPER/IRCCSRE
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 5

Brief Summary

Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD). EMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications. In Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers. Given the lack of randomized controlled trials comparing EMR and ESD in Western populations, this study aims to provide robust clinical evidence to guide treatment decisions. The primary objective of this study is to compare the recurrence/residual adenomatous tissue rate at 6 and 12 months between EMR and ESD in patients with LST-G lesions of the colon and rectum

Conditions

Colorectal Cancer

Keywords

Endoscopic Mucosal Resection (EMR); Endoscopic submucosal dissection (ESD); Laterally spreading tumors (LST)

Outcome Measures

Primary Outcomes (1)

• Recurrence/Adenomatous Residual Rate

  Proportion of patients with local recurrence or residual adenomatous tissue, confirmed through follow-up colonoscopies and histopathological examination.

  6 and 12 months after treatment

Secondary Outcomes (5)

• Complete Resection Rate

  6 and 12 months after treatment

• Differences in Procedure Time

  Up to 2 months

• Bleeding Rate

  During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment

• Perforation Rate

  During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment

• Overall Complication Rate

  24 hours after treatment

Study Arms (2)

Endoscopic Mucosal Resection (EMR)

ACTIVE COMPARATOR

Procedure: Endoscopic Mucosal Resection (EMR)

Endoscopic Submucosal Dissection (ESD)

EXPERIMENTAL

Procedure: Endoscopic Submucosal Dissection (ESD)

Interventions

Endoscopic Mucosal Resection (EMR) PROCEDURE

atients assigned to this arm will undergo Endoscopic Mucosal Resection (EMR), a standard endoscopic technique that involves the resection of colorectal Laterally Spreading Tumors - Granular type (LST-G) using a diathermic snare with submucosal injection. The procedure may be performed en bloc or in a piecemeal fashion, depending on lesion size and characteristics. EMR is widely accepted for lesions with low submucosal invasion risk but has a higher recurrence rate than ESD.

Endoscopic Mucosal Resection (EMR)

Endoscopic Submucosal Dissection (ESD) PROCEDURE

Patients assigned to this arm will undergo Endoscopic Submucosal Dissection (ESD), an advanced endoscopic technique that allows for en bloc resection of large colorectal Laterally Spreading Tumors - Granular type (LST-G). The procedure involves the use of specialized knives to dissect the submucosal layer, ensuring complete resection with histologically clear margins (R0 resection). ESD has been associated with lower recurrence rates but requires a high level of expertise, longer procedural times, and carries a higher risk of complications.

Endoscopic Submucosal Dissection (ESD)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection.
• Life expectancy \> 10 years.
• Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.

You may not qualify if:

• Diagnosis of Laterally Spreading Tumor - Non-Granular Type (LST-NG).
• Presence of depressed areas within the lesion.
• Lesions located on a scar or anastomosis site.
• Lesions classified as Kudo Vi or Vn pattern.
• History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).
• Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis, Lynch syndrome).

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (5)

IRCCS Azienda Ospedaliero Universitaria di Bologna - Sant'Orsola Malpighi

Bologna, Italy

RECRUITING

Ente Ospedaliero Ospedali Galliera

Genova, Italy

RECRUITING

Università Vita Salute - IRCCS

Milan, Italy

RECRUITING

Ospedale Civile di Baggiovara

Modena, Italy

RECRUITING

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

RECRUITING

Related Publications (11)

• Bogie RMM, Veldman MHJ, Snijders LARS, Winkens B, Kaltenbach T, Masclee AAM, Matsuda T, Rondagh EJA, Soetikno R, Tanaka S, Chiu HM, Sanduleanu-Dascalescu S. Endoscopic subtypes of colorectal laterally spreading tumors (LSTs) and the risk of submucosal invasion: a meta-analysis. Endoscopy. 2018 Mar;50(3):263-282. doi: 10.1055/s-0043-121144. Epub 2017 Nov 27.

  PMID: 29179230 BACKGROUND

• Kudo S, Hirota S, Nakajima T, Hosobe S, Kusaka H, Kobayashi T, Himori M, Yagyuu A. Colorectal tumours and pit pattern. J Clin Pathol. 1994 Oct;47(10):880-5. doi: 10.1136/jcp.47.10.880.

  PMID: 7962600 BACKGROUND

• Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikematsu H, Igarashi M, Saitoh Y, Inoue Y, Kobayashi K, Hisabe T, Tsuruta O, Sano Y, Yamano H, Shimizu S, Yahagi N, Watanabe T, Nakamura H, Fujii T, Ishikawa H, Sugihara K; Colorectal Endoscopic Resection Standardization Implementation Working Group of the Japanese Society for Cancer of the Colon and Rectum, Tokyo, Japan. Local recurrence after endoscopic resection for large colorectal neoplasia: a multicenter prospective study in Japan. Am J Gastroenterol. 2015 May;110(5):697-707. doi: 10.1038/ajg.2015.96. Epub 2015 Apr 7.

  PMID: 25848926 BACKGROUND

• Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.

  PMID: 28212588 BACKGROUND

• Fujiya M, Tanaka K, Dokoshi T, Tominaga M, Ueno N, Inaba Y, Ito T, Moriichi K, Kohgo Y. Efficacy and adverse events of EMR and endoscopic submucosal dissection for the treatment of colon neoplasms: a meta-analysis of studies comparing EMR and endoscopic submucosal dissection. Gastrointest Endosc. 2015 Mar;81(3):583-95. doi: 10.1016/j.gie.2014.07.034. Epub 2015 Jan 13.

  PMID: 25592748 BACKGROUND

• Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.

  PMID: 24986245 BACKGROUND

• Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T, Repici A, Vieth M, De Ceglie A, Amato A, Berr F, Bhandari P, Bialek A, Conio M, Haringsma J, Langner C, Meisner S, Messmann H, Morino M, Neuhaus H, Piessevaux H, Rugge M, Saunders BP, Robaszkiewicz M, Seewald S, Kashin S, Dumonceau JM, Hassan C, Deprez PH. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Sep;47(9):829-54. doi: 10.1055/s-0034-1392882. Epub 2015 Aug 28.

  PMID: 26317585 BACKGROUND

• 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.

  PMID: 25652022 BACKGROUND

• Fuccio L, Repici A, Hassan C, Ponchon T, Bhandari P, Jover R, Triantafyllou K, Mandolesi D, Frazzoni L, Bellisario C, Bazzoli F, Sharma P, Rosch T, Rex DK. Why attempt en bloc resection of non-pedunculated colorectal adenomas? A systematic review of the prevalence of superficial submucosal invasive cancer after endoscopic submucosal dissection. Gut. 2018 Aug;67(8):1464-1474. doi: 10.1136/gutjnl-2017-315103. Epub 2017 Dec 5.

  PMID: 29208675 BACKGROUND

• Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41.

  PMID: 19638919 BACKGROUND

• Yoshida M, Kakushima N, Mori K, Igarashi K, Kawata N, Tanaka M, Takizawa K, Ito S, Imai K, Hotta K, Ishiwatari H, Matsubayashi H, Ono H. Learning curve and clinical outcome of gastric endoscopic submucosal dissection performed by trainee operators. Surg Endosc. 2017 Sep;31(9):3614-3622. doi: 10.1007/s00464-016-5393-9. Epub 2016 Dec 30.

  PMID: 28039646 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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

• Sassatelli Romano, MD

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucarini Matteo, MD

CONTACT

+39 0522 296423; matteo.lucarini@ausl.re.it

Study Design

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

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 7, 2025
• Study Start: November 18, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)