Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy

NCT01879904 | Completed DMC

• 1 other identifier: P081202
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colorectal Neoplasms; Endoscopic Submucosal Dissection

Keywords

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• monobloc resection rate

  1 year

• complication rate

  1 year

• complete resection predictive factors

  1 year

• Curative resection rate (1 year)

  1 year

Study Arms (1)

Endoscopic submucosal dissection (ESD)

EXPERIMENTAL

Endoscopic submucosal dissection (ESD)

Procedure: Endoscopic submucosal dissection (ESD)

Interventions

Endoscopic submucosal dissection (ESD) PROCEDURE

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.

Also known as: endoscopic submucosal dissection

Endoscopic submucosal dissection (ESD)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Gastroenterology Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75015, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Christophe Cellier, PD, PhD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 18, 2013
• Study Start: February 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2013-06

Locations

FR (1)