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

Endoscopic Submucosal Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482491
• Other study ID #: Endoscopic Characterization
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2020
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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.

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Exclusion Criteria:

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

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Related Conditions & MeSH terms

• Endoscopic Submucosal Dissection

Intervention

Procedure:
• Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection

Locations

Country	Name	City	State
France	Edouard Herriot Hospital	Lyon	Rhône Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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