Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
This study is currently recruiting participants.
Verified by Cantonal Hospital of St. Gallen, September 2007
Sponsored by: Cantonal Hospital of St. Gallen
Information provided by: Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00531297
  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 we 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 III

MedlinePlus related topics: Cancer Endoscopy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

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

Primary Outcome Measures:
  • Recurrence rate [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Morbidity (>= CTCAE grade 3) [ Time Frame: 30 days ]
  • perioperative mortality [ Time Frame: 30 days ]

Estimated Enrollment: 96
Study Start Date: December 2005
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531297

Contacts
Contact: Andreas Zerz, MD +41 71 858 1428 andreas.zerz@kssg.ch

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

Study ID Numbers: EKSG 05/072/2B
Study First Received: September 17, 2007
Last Updated: September 17, 2007
ClinicalTrials.gov Identifier: NCT00531297  
Health Authority: Switzerland: Ethikkommission

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Rectal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009