Clinical trial NCT03470883: Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors
Official title: Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Colorectal Tumors
Keywords: endoscopic resection
colorectal adenomas
Colorectal adenocarcinomas
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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.

Eligibility 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

Primary outcomes:
measure: Complete long-term remission (> 12 months)
timeFrame: 13 months
Secondary outcomes:
measure: Absence of residual lesion on early control (3 to 6 months)
timeFrame: 3 to 6 months
measure: Rates of medium and long-term recurrence
timeFrame: 13 months
measure: Management of medium and long-term recurrence
timeFrame: 13 months
measure: Morbidity and mortality rates
timeFrame: 13 months
measure: Lymph node or visceral metastatic evolution rate
timeFrame: 13 months
measure: Endoscopic description and anatomopathological results
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Philippe RATONE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut. 2002 Jul;51(1):130-1. doi: 10.1136/gut.51.1.130.
citation: 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.
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: 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: 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.