Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Cantonal Hospital of St. Gallen
Sponsor:
Collaborators:
Heidelberg University
University of Basel
University of Krakau, Department of Visceral surgery
Information provided by (Responsible Party):
Ignazio Tarantino, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00531297
First received: September 17, 2007
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Rectal Neoplasms
Procedure: endoscopic posterior mesorectal resection
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity (>= CTCAE grade 3) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Perioperative mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: December 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531297

Contacts
Contact: Andreas Zerz, MD +41 61 436 2182 andreas.zerz@ksbh.ch

Locations
Switzerland
Department of Surgery Recruiting
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Heidelberg University
University of Basel
University of Krakau, Department of Visceral surgery
Investigators
Principal Investigator: Andreas Zerz, MD Cantonal Hospital St. Gallen
  More Information

No publications provided

Responsible Party: Ignazio Tarantino, M.D., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00531297     History of Changes
Other Study ID Numbers: EKSG 05/072/2B
Study First Received: September 17, 2007
Last Updated: January 23, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 26, 2014