Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00531297
• Other study ID #: EKSG 05/072/2B
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2005
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Department of Surgery	St. Gallen

Sponsors (4)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen	Heidelberg University, University of Basel, University of Krakau, Department of Visceral surgery

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate		5 years
Secondary	Morbidity (>= CTCAE grade 3)		30 days
Secondary	Perioperative mortality		30 days