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

Superficial Colorectal Tumors Clinical Trial

— REC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470883
• Other study ID #: REC-IPC 2017-035
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: November 2, 2017

Study information

• Verified date: March 2018
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Superficial Colorectal Tumors

Intervention

Other:
• Evaluation of the long-term complete remission rate (> 12 months)
Evaluation of the long-term complete remission rate (> 12 months)

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (5)

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 — View Citation

Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut. 2002 Jul;51(1):130-1. — View 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, Poncho — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete long-term remission (> 12 months)	Evaluation of the long-term complete remission rate (> 12 months)	13 months
Secondary	Absence of residual lesion on early control (3 to 6 months)	Medium-term response rate (3 to 6 months)	3 to 6 months
Secondary	Rates of medium and long-term recurrence	Recurrence rate in the medium and long term	13 months
Secondary	Management of medium and long-term recurrence	Management of recurrence (endoscopic revision or surgery)	13 months
Secondary	Morbidity and mortality rates	Morbidity and mortality rate of endoscopic resection	13 months
Secondary	Lymph node or visceral metastatic evolution rate	Rate of pejorative lymph node or metastatic evolution (especially for lesions with microinfiltration of the submucosa)	13 months
Secondary	Endoscopic description and anatomopathological results	Endoscopic and / or anatomopathological predictive factors of success (complete long-term remission)	1 day