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NCT Number: NCT04592003

French Colorectal ESD Cohort in Experts Centers

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens, Amiens, France

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About this study

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients addressed for a colorectal ESD

Exclusion criteria

Opposition notified in the context of a non-opposition form after reading the information notice

Treatment and study plan

Endoscopic submucosal dissection

Procedure

Endoscopic submucosal dissection

Primary outcomes

  1. R0 Resection rate of submucosal dissection for superficial colorectal lesions

    Time frame: Month 1

    R0 Resection rate according to the definition of of the European Society of Gastrointestinal Endoscopy.

Secondary outcomes

  1. Endoscopic recurrence rate during the first endoscopic follow-up

    Time frame: Month 6

    Recurrence during the first endoscopic follow-up will be defined by the presence of adenoma or adenocarcinoma at the resection scar, whether visible or not, and confirmed by systematic biopsies of the resection scar.

  2. Monobloc resection rate

    Time frame: Day 1

    Monobloc resection is defined as resection of the lesion in a single piece.

  3. Monobloc resection rate exclusively in ESD.

    Time frame: Day 1

    Monobloc resection exclusively by ESD is defined as resection of the lesion in a single piece using submucosal dissection only, without the use of a diathermic loop (hybrid technique).

  4. Curative resection rate

    Time frame: Month 1

    Curative resection is defined according to the recommendations of the European Society of Digestive Endoscopy as a monobloc R0 dissection without any negative anatomopathological criteria (well-differentiated lesion, no emboli, no budding > 1, submucosal infiltration < 1 mm).

  5. Optimal dissection rate

    Time frame: Month 1

    Optimal dissection is defined as exclusive R0 dissection without perforation, with a resection speed > 20 mm2/min.

  6. 30-day complication rate

    Time frame: Month 1

    • Per-procedural perforation: breach of the colonic musculature with visualization of the peritoneal cavity.
    • Post-procedural perforation (≤ 30 days): abdominal pain associated with fever or inflammatory syndrome and presence of extraluminal air on abdominal-pelvic CT scan, in the absence of per-procedural perforation.
    • Per-procedural hemorrhage: considered a complication only if it leads to interruption of the procedure.
    • Post-procedural hemorrhage: rectal bleeding or melena requiring hospitalization (or prolonged hospitalization) or endoscopic hemostasis.
  7. Curative endoscopic resection rate without surgical management at 36 months

    Time frame: Month 36

    Curative endoscopic resection without surgery is defined by the absence of adenoma or adenocarcinoma at the resection scar after 36 months of follow-up, regardless of the number of endoscopic treatments required.

  8. Number of metachronous colorectal lesions at 36 months

    Time frame: Month 36

    A metachronous lesion is defined as the presence of a new superficial colorectal lesion during one of the endoscopic checks, a lesion not visualized during one of the previous examinations.

  9. Surgery rate at 36 months

    Time frame: Month 36

    Any colorectal surgery will be taken into account, whether due to failure of the endoscopic procedure, recurrence, a complication of the procedure, or an anatomopathological reason.

  10. Recurrence rate at 36 months

    Time frame: Month 36

    Recurrence at 36 months will be defined by the presence of adenoma or adenocarcinoma at the resection scar, whether visible or not, and confirmed by systematic biopsies of the resection scar.

  11. Effectiveness of histological prediction of superficial colorectal lesions treated according to the technological tools used.

    Time frame: Month 1

    The histological prediction of resected lesions will be established using validated classifications (Paris, SANO, NICE, KUDO, JNET, CONECTT). It will be compared with the definitive histological results to assess their sensitivity, specificity, and diagnostic accuracy within the cohort.

  12. Impact of center volume on oncological outcomes, technical outcomes, and procedural complications.

    Time frame: Month 1

    Oncological, technical, and complication outcomes will be analyzed according to the annual volume of the centers (low volume = < 50 ESDs per year; intermediate volume = between 50 and 100 procedures per year; high volume = > 100 procedures per year).

  13. Compare oncological and technical outcomes and procedural complications based on colonic or rectal location.

    Time frame: Month 1

    Oncological, technical, and complication outcomes will be analyzed according to the colonic or rectal location of the lesion.

  14. Compare procedural outcomes based on the different traction strategies used

    Time frame: Month 1

    Oncological, technical, and complication outcomes will be analyzed according to the traction system used for the procedure, matching lesions according to difficulty criteria validated by the literature.

  15. Analyze the learning curve of new trainees at the time of implementation of the submucosal dissection curriculum of the French Society of Digestive Endoscopy.

    Time frame: statitistic analysis

    The learning curve of trainees will be used to evaluate oncological, technical, and complication outcomes using the LC CUSUM method.

  16. Creation of a difficulty score predicting the success of ESD (R0 resection without perforation)

    Time frame: Month 1

    A difficulty score predicting success (R0 without perforation) will be created by performing a multivariate analysis according to the TRIPOD GUIDELINES using a derivation cohort and validated on a derivation cohort.

Study contacts

Contact information is provided by the study sponsor or research team.

Juge Sandra, Dr

CONTACT

[email protected]

05 55 05 64 14

Jérémie Jacques, Pr

CONTACT

[email protected]

05 55 05 87 72

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: FECCo

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2020
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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