Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy
DISSECMUC
DISSECMUC
Sponsor study identifier
interventional
48
1 country
1
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)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):
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 12, 2013
Actual (reported)June 18, 2013
Actual (reported)July 2013
Actual (reported)July 2013
Actual (reported)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
monobloc resection rate
1 year
complication rate
1 year
complete resection predictive factors
1 year
Curative resection rate (1 year)
1 year
Endoscopic submucosal dissection (ESD)
This study is suggest 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gastroenterology Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris
Paris, 75015, France
Christophe Cellier, PD, PhD
Hôpital Européen Georges-Pompidou
48 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2013
First Posted
June 18, 2013
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
September 18, 2013
Record last verified: 2013-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: