Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

NCT ID: NCT00531297

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-01
• Study Completion Date: 2018-08-31

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.

Conditions

Rectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

endoscopic posterior mesorectal resection

Group Type: EXPERIMENTAL

endoscopic posterior mesorectal resection

Intervention Type: PROCEDURE

6 weeks after local excision of a T1 rectal cancer a rectum sparing endoscopic removal of the dorsal part of the mesorectum by EPMR is performed.

Interventions

endoscopic posterior mesorectal resection

6 weeks after local excision of a T1 rectal cancer a rectum sparing endoscopic removal of the dorsal part of the mesorectum by EPMR is performed.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: collaborator

University of Krakau, Department of Visceral surgery

UNKNOWN

Sponsor Role: collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Ignazio Tarantino

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Zerz, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen

Locations

Department of Surgery

Sankt Gallen, , Switzerland

Countries

Switzerland

Other Identifiers

EKSG 05/072/2B

Identifier Type: -

Identifier Source: org_study_id