Clinical trial NCT06815406: 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
Official title: Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection (EMR) Vs. Endoscopic Submucosal Dissection (ESD): a Multicenter Randomized Controlled Trial ( ESD Vs EMR )
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Endoscopic Mucosal Resection (EMR)
Endoscopic submucosal dissection (ESD)
Laterally spreading tumors (LST)
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2025-02-07
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Recurrence/Adenomatous Residual Rate
timeFrame: 6 and 12 months after treatment
Secondary outcomes:
measure: Complete Resection Rate
timeFrame: 6 and 12 months after treatment
measure: Differences in Procedure Time
timeFrame: Up to 2 months
measure: Bleeding Rate
timeFrame: During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment
measure: Perforation Rate
timeFrame: During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment
measure: Overall Complication Rate
timeFrame: 24 hours after treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria di Bologna - Sant'Orsola Malpighi
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera
city: Milano
country: Italy
facility: Università Vita Salute - IRCCS
city: Modena
country: Italy
facility: Ospedale Civile di Baggiovara
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Sassatelli Romano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.