Skip to content

Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00531297
Enrollment
18
Registered
2007-09-18
Start date
2005-12-01
Completion date
2018-08-31
Last updated
2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

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.

Interventions

PROCEDUREendoscopic 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.

Sponsors

Heidelberg University
CollaboratorOTHER
University of Basel
CollaboratorOTHER
University of Krakau, Department of Visceral surgery
CollaboratorUNKNOWN
Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Recurrence rate5 years

Secondary

MeasureTime frame
Morbidity (>= CTCAE grade 3)30 days
Perioperative mortality30 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026