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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04482491
Enrollment
90
Registered
2020-07-22
Start date
2019-01-01
Completion date
2020-01-01
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Submucosal Dissection

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

Interventions

PROCEDUREEndoscopic Submucosal Dissection

Endoscopic Submucosal Dissection

Sponsors

Hôpital Edouard Herriot
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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. . \-

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026