Colorectal Neoplasms Clinical Trial
— DISSECMUCOfficial title:
Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy
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 therapy. This technique is actually performed routinely in Japan and
experience is limited in Europe, with few data in the literature.
This study is suggested to patients with superficial medium or distal rectal tumors. The
lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and
chromoendoscopy. Then, marking around the lesions was performed. Local injection was made
using injection needle, and then mucosal incision was performed around the lesion using
endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel
coagulation were practiced using primary hemostatic forceps during the procedure.
Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement,
undifferentiated, free margin less than 1 mm), a surgical resection is performed.
All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with
biopsies):
- For complete resection, an endoscopic control was performed at 1 year.
- For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic
control was performed at 1 year.
At one year, patient with incomplete resection have a surgical resection.
Status | Completed |
Enrollment | 48 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Gastroenterology Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | curative resection rate (3 month) | Evaluate the curative R0 resection rate at 3 months without surgical therapy, in patients with superficial rectal tumours | 3 months | No |
Secondary | monobloc resection rate | evaluate the monobloc resection rate | 1 year | No |
Secondary | complication rate | evaluate the complication rate | 1 year | Yes |
Secondary | complete resection predictive factors | evaluate the complete resection predictive factors | 1 year | No |
Secondary | Curative resection rate (1 year) | Evaluate the curative R0 resection rate at 1 year without surgical therapy, in patients with superficial rectal tumours | 1 year | No |
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