Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT00531297|
Recruitment Status : Recruiting
First Posted : September 18, 2007
Last Update Posted : January 24, 2013
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 or disease||Intervention/treatment||Phase|
|Rectal Neoplasms||Procedure: endoscopic posterior mesorectal resection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer|
|Study Start Date :||December 2005|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- 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.
- Recurrence rate [ Time Frame: 5 years ]
- Morbidity (>= CTCAE grade 3) [ Time Frame: 30 days ]
- Perioperative mortality [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531297
|Contact: Andreas Zerz, MD||+41 61 436 firstname.lastname@example.org|
|Department of Surgery||Recruiting|
|St. Gallen, Switzerland, 9007|
|Principal Investigator:||Andreas Zerz, MD||Cantonal Hospital St. Gallen|