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Follow-up After Oncological Resection by Endoscopic Colorectal ESD

ConditionColorectal Neoplasms
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

Colorectal cancer is a common and leading cause of death. Pre-cancerous lesions, as well as some so-called superficial cancers, can be resected via endoscopy. The technique chosen in the case of extensive lesions or superficial cancer is submucosal dissection. This technique helps avoid surgery, which has a higher morbidity and mortality (especially due to the non-preservation of the organ).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient (18 years or older).

Presumed diagnosis of localized superficial colorectal cancer (T1) during endoscopy using the Conecct classification, confirmed by subsequent histopathological analysis.

Patient included in the FECCo registry since September 2019 for submucosal dissection.

Histological analysis of the resection specimen revealing a superficial colorectal adenocarcinoma with high risk of lymphatic recurrence, defined by at least one of the following criteria: submucosal invasion depth ≥ 1000 microns, tumor budding grade ≥ 2, presence of lymphatic and/or vascular emboli.

Disqualifiers

History of Crohn's disease (ICD-10: K50) or ulcerative colitis (ICD-10: K51).

History of familial adenomatous polyposis and/or genetic predisposition to colorectal cancer (ICD-10: D12.6+0/1/2/4/5 and 6).

Malignant tumor of the colon staged ≥ T2.

Patients not included in the FECCo registry.

Trial population

The study population will be drawn from the FECCo registry and will include patients who have undergone endoscopic resection using ESD, with final histological analysis confirming the presence of a colorectal cancer at high risk of lymph node recurrence.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Surgery, Radiochimiotherapy

    Procedure/Surgery

    Analysis of medical data and residual biological samples

Treatment groups

1,200 Participants
are divided into 1 treatment group
Group A: Surgery, Radiochimiotherapy, Surveillance1 intervention

Trial outcomes

Primary outcomes

1

Recurrence-free survival

Proportion of patients who remain free of oncological recurrence, either locoregional and/or metastatic, at 12 months after DSM.

Time frame
12 months visit

Secondary outcomes

1

Post-adjuvant treatment mortality

Proportion of patients who have died from any cause at 1, 2, and 3 years after treatment.

Time frame
12 months, 24 months and 36 months visits
2

Recurrence-free survival

Compare recurrence-free survival after local excision complicated by intraoperative perforation versus uncomplicated cases.

Time frame
12 months visit
3

Adherence to oncological follow-up recommendations

Evaluate adherence to oncological follow-up recommendations proposed in multidisciplinary tumor board (MTB) meetings and/or by the operator.

Time frame
12 months visit
4

Oncological risk factors

Evaluate oncological risk factors for lymph node and/or metastatic recurrence following local excision of a superficial colorectal cancer.

Time frame
12 months visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: