Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
Primary Purpose
Rectal Neoplasms
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
endoscopic posterior mesorectal resection
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasms
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
Sites / Locations
- Department of Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
endoscopic posterior mesorectal resection
Outcomes
Primary Outcome Measures
Recurrence rate
Secondary Outcome Measures
Morbidity (>= CTCAE grade 3)
Perioperative mortality
Full Information
NCT ID
NCT00531297
First Posted
September 17, 2007
Last Updated
September 12, 2018
Sponsor
Cantonal Hospital of St. Gallen
Collaborators
Heidelberg University, University of Basel, University of Krakau, Department of Visceral surgery
1. Study Identification
Unique Protocol Identification Number
NCT00531297
Brief Title
Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
Official Title
Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
December 1, 2005 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen
Collaborators
Heidelberg University, University of Basel, University of Krakau, Department of Visceral surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
endoscopic posterior mesorectal resection
Intervention Type
Procedure
Intervention Name(s)
endoscopic posterior mesorectal resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Morbidity (>= CTCAE grade 3)
Time Frame
30 days
Title
Perioperative mortality
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Zerz, MD
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
We'll reach out to this number within 24 hrs