Status:
COMPLETED
Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Colorectal Neoplasms
Endoscopic Submucosal Dissection
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Superficial rectal tumors could be removed by ESD with two major advantages showed by the literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was lower than ERM therap...
Detailed Description
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01879904
Start Date
February 1 2010
End Date
July 1 2013
Last Update
September 18 2013
Active Locations (1)
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1
Gastroenterology Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris
Paris, France, 75015