Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

• Sponsor: Cantonal Hospital of St. Gallen (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00531297
• Collaborator: Heidelberg University (Other), University of Basel (Other), University of Krakau, Department of Visceral surgery (Other)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 153
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms	Procedure: endoscopic posterior mesorectal resection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer
• Actual Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment arm endoscopic posterior mesorectal resection	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

Primary Outcome Measures

1. Recurrence rate [5 years]

Secondary Outcome Measures

1. Morbidity (>= CTCAE grade 3) [30 days]

2. Perioperative mortality [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ignazio Tarantino, M.D., Cantonal Hospital of St. Gallen
• ClinicalTrials.gov Identifier: NCT00531297
• Other Study ID Numbers: EKSG 05/072/2B
• First Posted: Sep 18, 2007
• Last Update Posted: Sep 13, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Sep 13, 2018