Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors (REC)

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ClinicalTrials.gov Identifier: NCT03470883

Recruitment Status : Completed

First Posted : March 20, 2018

Last Update Posted : May 24, 2018

Sponsor:

Information provided by (Responsible Party):

Institut Paoli-Calmettes

Study Description

Brief Summary:

To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.

Condition or disease	Intervention/treatment
Superficial Colorectal Tumors	Other: Evaluation of the long-term complete remission rate (> 12 months)

Detailed Description:

Intra-mucous colorectal neoplasia lesions (or even with minimal mucosal infiltration), formerly treated surgically, are increasingly treated endoscopically.

The IPC as a center for interventional endoscopy has been taking care of these lesions for several years.

Resection techniques have diversified since the 2000s (polypectomy, monobloc or piecemeal mucosectomy, submucosal dissection ... etc) and the endoscopy team has developed its various techniques within the institute ; Practice has evolved and has not been studied or evaluated in recent years. The purpose of this study is to evaluate practices and to compare results with the literature, and to identify predictive factors for the failure or success of endoscopic treatment of these early neoplastic lesions.

Study Design

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Study Type :	Observational
Actual Enrollment :	100 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors
Actual Study Start Date :	January 1, 2012
Actual Primary Completion Date :	December 31, 2016
Actual Study Completion Date :	November 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colorectal Cancer Endoscopy

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
endoscopic resection of a colorectal lesion Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.	Other: Evaluation of the long-term complete remission rate (> 12 months) Evaluation of the long-term complete remission rate (> 12 months)

Outcome Measures

Primary Outcome Measures :

Complete long-term remission (> 12 months) [ Time Frame: 13 months ]
Evaluation of the long-term complete remission rate (> 12 months)

Secondary Outcome Measures :

Absence of residual lesion on early control (3 to 6 months) [ Time Frame: 3 to 6 months ]
Medium-term response rate (3 to 6 months)
Rates of medium and long-term recurrence [ Time Frame: 13 months ]
Recurrence rate in the medium and long term
Management of medium and long-term recurrence [ Time Frame: 13 months ]
Management of recurrence (endoscopic revision or surgery)
Morbidity and mortality rates [ Time Frame: 13 months ]
Morbidity and mortality rate of endoscopic resection
Lymph node or visceral metastatic evolution rate [ Time Frame: 13 months ]
Rate of pejorative lymph node or metastatic evolution (especially for lesions with microinfiltration of the submucosa)
Endoscopic description and anatomopathological results [ Time Frame: 1 day ]
Endoscopic and / or anatomopathological predictive factors of success (complete long-term remission)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification

Criteria

Inclusion Criteria:

Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.

Exclusion Criteria:

Adenomas with low grade dysplasia
Endoscopic control not available

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470883

Locations

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France
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France, 13009

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

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Principal Investigator:	Jean-Philippe RATONE	Institut Paoli-Calmettes

More Information

Publications of Results:

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.

Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26. Review.

Other Publications:

Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut. 2002 Jul;51(1):130-1.

Repici A, Pellicano R, Strangio G, Danese S, Fagoonee S, Malesci A. Endoscopic mucosal resection for early colorectal neoplasia: pathologic basis, procedures, and outcomes. Dis Colon Rectum. 2009 Aug;52(8):1502-15. doi: 10.1007/DCR.0b013e3181a74d9b. Review.

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.

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Responsible Party:	Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:	NCT03470883
Other Study ID Numbers:	REC-IPC 2017-035
First Posted:	March 20, 2018 Key Record Dates
Last Update Posted:	May 24, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Institut Paoli-Calmettes:


endoscopic resection colorectal adenomas Colorectal adenocarcinomas

Additional relevant MeSH terms:

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

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