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OpenTrials
Completed

NCT Number: NCT03470883

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

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

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Key information

Conditions

Superficial Colorectal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Complete long-term remission (> 12 months)

    Time frame: 13 months

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

Secondary outcomes

  1. 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)

  2. Rates of medium and long-term recurrence

    Time frame: 13 months

    Recurrence rate in the medium and long term

  3. Management of medium and long-term recurrence

    Time frame: 13 months

    Management of recurrence (endoscopic revision or surgery)

  4. Morbidity and mortality rates

    Time frame: 13 months

    Morbidity and mortality rate of endoscopic resection

  5. 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)

  6. Endoscopic description and anatomopathological results

    Time frame: 1 day

    Endoscopic and / or anatomopathological predictive factors of success (complete long-term remission)

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: REC

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Mar 20, 2018
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.