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Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overOtherEKSG 05/072/2B
NCT00531297

Trial Description

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Kantonsspital - St. Gallen

Heidelberg University

Universitaetsspital-Basel

University of Krakau, Department of Visceral surgery

Andreas Zerz, MDPrincipal Investigator

Andreas Zerz, MDPh: +41 61 436 2182
  Email: andreas.zerz@ksbh.ch

Trial Sites

Switzerland
  St. Gallen
 Kantonsspital - St. Gallen

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00531297
ClinicalTrials.gov processed this data on March 27, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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