Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Rectal Neoplasms	Procedure: endoscopic posterior mesorectal resection	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	96 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. Recurrence rate [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. Morbidity (>= CTCAE grade 3) [ Time Frame: 30 days ]
2. Perioperative mortality [ Time Frame: 30 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	September 18, 2007
Last Update Posted:	January 24, 2013
Last Verified:	January 2013

Additional relevant MeSH terms:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site	Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases