Histological Prediction and Choice of the Resection Strategy in Front of a Colorectal Lesion > 2 cm: Prospective Comparison of Endoscopic Characterization, Non-targeted and Targeted Biopsies

NCT04482491 | Completed

• 1 other identifier: Endoscopic Characterization
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer has become a public health priority considering its increased prevalence and high mortality rate when diagnosed late. As a consequence, many countries have promoted and uptaken of colorectal cancer screening programs leading to an increasing detection of advanced but also superficial lesions ESGE (European Society of Gastrointestinal Endoscopy) guidelines states that the majority of those colonic and rectal superficial lesions can be removed in a curative way by standard polypectomy and/or by EMR (Endoscopic Mucosal Resection) and that ESD (Endoscopic Submucosal Dissection) can be considered for removal of colonic and rectal lesions with high suspicion of limited submucosal invasion. Histologically, a resection is curative for the patient when the adenocarcinoma is well-differentiated (G1/G2), with a depth of invasion ≤ sm1 (≤ 1 mm submucosal invasion), with no lymphovascular invasion nor budding and with lateral and deep margins free of cancer

Conditions

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• correlation between the histological prediction according to the CONECCT classification, the directed biopsy, the non-directed biopsy and the final histology of the completely resected part (R0).

  1 Year

Interventions

Endoscopic Submucosal Dissection PROCEDURE

Endoscopic Submucosal Dissection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hgh Risk Colorectal Cancer

You may qualify if:

• Patients with colorectal lesions\> 2 cm because any gastroenterologist must be able to resect 2 cm polyps on their own and therefore should never need to take biopsies to clarify the histology before resection.
• Patient consenting after information If the lesion is defined by an endoscopist as CONECCT IIA, simple adenoma, the lesion will be resected by en bloc mucosectomy or piece meal depending on its size (after a biopsy, secondary objective).
• If the lesion is defined by an endoscopist as CONECCT IIC, adenoma at risk or superficial cancer (\<1000µm depth), the lesion will be resected by R0 en bloc by mucosectomy or dissection if the lesion is greater than 20mm (after a biopsy, secondary objective).
• If the lesion is defined by an endoscopist as CONECCT III, deep adenocarcinoma (≥1000µm depth), it will be sampled from the most severe part by biopsy forceps and the patient will be referred to oncology or surgery according to the extension assessment .
• Pathology available of endoscopic or surgical resection piece Follow-up at 6 months after treatment for CONECCT IS, IIA, IIC lesions by endoscopic control and III by clinical or imaging control.

You may not qualify if:

• Metastatic lesion immediately before colonoscopy Patients under guardianship Age \<18 Pregnant woman Contraindication to colonoscopy.

Sponsors & Collaborators

• Hôpital Edouard Herriot: lead

Study Sites (1)

Edouard Herriot Hospital

Lyon, Auvergne-Rhône-Alpes, 69473, France

Location

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 22, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)