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Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy

18 Years
85 Years
Open (Enrolling)
Colorectal Neoplasms, Endoscopic Submucosal Dissection

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Trial Information

Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy

Colorectal neoplasia prevalence was 35 000 for a total number of 278 000 cancers in France
during 2000. Treatment of these cancers is based on local extension especially in the
digestive tract (stade) and on co-morbidities of the patient. There are many advantages to
treat these cancers at an early stade (involving mucosa or superficial submucosa), since
they are associated with a better prognosis with a lower cost-effectivness ratio. Indeed, in
2003 mean cost of treatment of colorectal cancer during the first year following diagnosis
was 24 000 €, whereas it was only 18 000 € for early stade and up to 36 000 € for the most
advanced stade. Transversal (1 week) and national survey of the French society of endoscopy
(SFED) during 8 years demonstrated that among 1 millions of endoscopies (3/4 being performed
with anesthesia), 8000 were performed for endosocpic treatment of early digestive cancers by
endoscopic mucosal resection (EMR) or more recently by endoscopic submucosal dissection
(ESD). One of the problems to diffuse these endoscopic treatments is the multiple tools
required to endotherapy, and the fact that this treatment is time-consuming, whereas a
simple ablation of polyps (polypectomy) smaller than 1.5 cm needs only 5 to 10 minutes. For
exemple, endotherapeutic tools for polypectomy (one needle and one polypectomy loop) costs
180 € and occasionally required a couple of clips when rare (1%) hemorrhage or exceptional
(1p1000) perforation occurred. Conversely, endotherapy tools for ESD of early mucosal or
submucosal digestive cancers larger than 1.5 cm up to 4-5 cm, costs 1500 €, including
needles, submucosal injected products, hook-knife, insulinated-knife and coagulation rasper.
So, the recent T2A codification gathers these two kinds of endoscopic treatment under the
same code, whatever the size of the lesion, whereas costs of tools required for their
treatment are notably different especially when there are performed for inpatients
hospitalized less that 2 days which is only charged 480 € added of 192 € and 53€ for salary
in private exercise or 914 € in public hospital, by the national and public healthcare
system. Beside the expertise required for EMR and ESD of larger early cancers, this cost
does not invite to increase the frequency of EMR or ESD, taking into account that this
treatment is better practised by two simultaneous endoscopists, one of them manipulating the
endoscope en endotherapy tools.

Inclusion Criteria:

- Patients with superficial medium or distal rectal tumors more than 1 cm in size

- Criteria for ESD were determined by the endoscopic characteristics and histological
findings of biopsy specimens

- Endoscopic ultrasonography (EUS) also was performed when the lesion was strongly
suspected of submucosal invasion.

- Age older than 18, younger than 85 years.

Exclusion Criteria:

- Lesion less than 10 mm in size

- Pedundulated lesion

- Suspicion of submucosal invasion (MRI or EUS)

- Distant metastasis on CTscan

- Coagulopathy

- Pregnancy

- Refusal to participate to the study or inability to consent

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

curative resection rate (3 month)

Outcome Description:

Evaluate the curative R0 resection rate at 3 months without surgical therapy, in patients with superficial rectal tumours

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Christophe Cellier, PD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Européen Georges Pompidou


France: Committee for the Protection of Personnes

Study ID:




Start Date:

February 2010

Completion Date:

July 2013

Related Keywords:

  • Colorectal Neoplasms
  • Endoscopic Submucosal Dissection
  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms