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Not yet recruitingNCT07871227FORCEUpdated Oct 16, 2026

Follow-up After Oncological Resection by Endoscopic Colorectal ESD (Endoscopic Submucosal Dissection)

An observational study in Colorectal Neoplasms, sponsored by University Hospital, Bordeaux. Not yet recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by University Hospital, Bordeaux · Observational

Updated Oct 16, 2026Eligibility revisedPrimary outcomes revised+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

French data from over 4,000 dissections (French Colorectal ESD Cohort in Experts Centers, FECCo, Clinical Trial NCT04592003) of LST (Lateral Spreading Tumor) or superficial colorectal cancer show reassuring results in terms of effectiveness with an 88% complete resection rate (R0) and safety with 1.2% of secondary surgery due to complications. Due to the absence of lymph node dissection compared to surgery, there is a theoretical risk of higher lymphatic recurrence with submucosal dissection. This study would allow for a better preoperative assessment of the benefit/risk ratio, as well as a more tailored therapeutic approach afterward based on the course of the resection and the analysis of the surgical specimen.

02

Conditions studied

  • Colorectal Neoplasms

Keywords

  • Rectal Cancer
  • Rectum Cancer
  • Submucosal dissection
  • Lymph node recurrence
  • Risk factors
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 French Colorectal ESD Cohort in Experts Centers (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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Documented objection through the non-opposition form following review of the information notice
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgery, Radiochimiotherapy, Surveillance

    Patients who underwent surgery, radiochimiotherapy or nothing.

    Procedure: Surgery, Radiochimiotherapy

Interventions

  • ProcedureSurgery, Radiochimiotherapy

    Analysis of medical data and residual biological samples

06

What researchers measure

Primary outcomes

  1. Recurrence-free survival

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

    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

  5. Healthcare resource utilization.

    Compare healthcare resource utilization.

    Time frame: at 30 days, 3, 12, 24 and 36 months

  6. New histo-prognostic risk factors

    Investigate new histo-prognostic risk factors using molecular biology and proteomic profiling on submucosal dissection specimens.

    Time frame: 12 months visit

07

Study locations

14 sites
  • Clinique de l'Anjou
    Angers, 49000, France
    • Edouard CHABRUN, MD · Contact · echabrun@gmail.com · +33241241580
    • Edouard CHABRUN, MD · Principal investigator
  • CHU Dijon Bourgogne
    Dijon, 21079, France
  • CHU de Limoges
    Limoges, 87042, France
  • Hospices civils de Lyon - Hôpital Edouard Herriot
    Lyon, 69003, France
  • Clinique Jean Mermoz
    Lyon, 69008, France
  • Clinique Jules Verne
    Nantes, 44300, France
  • CHU Nîmes
    Nîmes, 30029, France
  • AP-HP Hôpital Cochin
    Paris, 75014, France
    • Arthur BELLE, MD · Contact · arthur.belle@aphp.fr · +33158414243
    • Arthur BELLE, MD · Principal investigator
  • Paris Saint Joseph
    Paris, 75014, France
    • Yann LE BALEUR, MD · Contact · ylebaleur@ghpsj.fr · +33144123009
    • Yann LE BALEUR, MD · Principal investigator
  • AP-HP Hôpital Européen Georges-Pompidou
    Paris, 75015, France
    • Guillaume PERROD, MD · Contact · guillaume.perrod@aphp.fr · +33156095700
    • Guillaume PERROD, MD · Principal investigator
  • CHU de Bordeaux
    Pessac, 33604, France
  • CHU de Rennes
    Rennes, 35033, France
  • Clinique Santé Atlantique
    Saint-Herblain, 44800, France
  • CHRU de Nancy
    Vandœuvre-lès-Nancy, 54511, France
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2030, 50 months later.

Of 461 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 132. This study's planned 50 months is below that.

Counting every sponsor, half of 562 studies reached it within 53 months; a quarter within 28 and three quarters within 103.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Oct 2026
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
eligibility and primary outcomes
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 16, 2026
    Eligibility Criteria revised
    Primary outcomes Revised (1 change)
    + 1 other change: identifiers
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07871227
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 16, 2026

Study contacts

Arthur BERGER, MD
Contact
arthur.berger@chu-bordeaux.fr
+335 56 79 56 79
Francois TOQUER
Contact
francois.tocquer@chu-bordeaux.fr

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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