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Completed

NCT Number: NCT04647266

Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions

The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.

Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.

There is currently no score established for the colo-rectal endoscopic submucosal dissection.

* To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital. * Allow to obtain an estimation of number of patients required for a larger study.

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Key information

Conditions

Polyp of Colon Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Brabois

Nancy, Meurthe ET Moselle, 54000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:
  • Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma
  • Mucosal tumors with submucosal fibrosis
  • Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis
  • Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus
  • Male or female patients aged ≥ 18 years old
  • Patients able to fill in questionnaires written in French

Exclusion criteria

  • Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)

Treatment and study plan

Endoscopic submucosal dissection

Procedure

endoscopic submucosal dissection

Primary outcomes

  1. To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.

    Time frame: From 2016 to 2020

Secondary outcomes

  1. Allow to obtain an estimation of number of patients required for a larger study

    Time frame: From 2016 to 2020

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 30, 2020
Registry last updated
Nov 30, 2020

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.

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