Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Not Applicable

Terminated

• Conditions: Rectal Neoplasms
• Interventions: Procedure: endoscopic posterior mesorectal resection

• Registration Number: NCT00531297
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or even abdominoperineal resection are linked to the risk of locoregional recurrence of about 10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly, in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or radiotherapy were developed, given the uncertainty about the lymph node stage. Another approach was to identify histological risk criteria in the primary tumor in terms of defining the limits of rectum-sparing therapy.

In earlier experimental and clinical studies the investigators researched and applied dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this technique becomes all the more significant, as the perineal approach makes it possible to perform an endoscopic posterior mesorectal resection (EPMR) in combination with rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be removed and histologically examined. As a consequence EPMR should lower the loco-regional recurrence rate, since the most common causes of such are pre-existent but so far not detectable lymph node metastases besides the incomplete resection of the primary tumor.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-01
• Study First Submitted: 2007-09-17
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Stage T1 (only)
• Over 18 years old
• Patient's consent
• Previous R0 resection of rectal tumor

Exclusion Criteria

• Metastases (M1)
• Neoadjuvant chemotherapy or radiotherapy
• Meta- or synchronous tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	endoscopic posterior mesorectal resection	endoscopic posterior mesorectal resection

Primary Outcome Measures

Name	Time	Method
Recurrence rate	5 years

Secondary Outcome Measures

Name	Time	Method
Morbidity (>= CTCAE grade 3)	30 days
Perioperative mortality	30 days

Trial Locations

Locations (1)

Department of Surgery; 🇨🇭 St. Gallen, Switzerland