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TerminatedNCT00531297Updated Sep 13, 2018

Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

An interventional study of endoscopic posterior mesorectal resection in Rectal Neoplasms, sponsored by Cantonal Hospital of St. Gallen. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-13.

Sponsored by Cantonal Hospital of St. Gallen · Not applicable, Interventional, and Treatment

Why this study was terminated
low recruitment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2005, registered Sep 2007).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rectal Neoplasms

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 18 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Metastases (M1)
  • Neoadjuvant chemotherapy or radiotherapy
  • Meta- or synchronous tumors
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Treatment arm

    endoscopic posterior mesorectal resection

    Procedure: endoscopic posterior mesorectal resection

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.

06

What researchers measure

Primary outcomes

  1. Recurrence rate

    Time frame: 5 years

Secondary outcomes

  1. Morbidity (>= CTCAE grade 3)

    Time frame: 30 days

  2. Perioperative mortality

    Time frame: 30 days

07

Study locations

1 site
  • Department of Surgery
    St. Gallen, 9007, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00531297
Lead sponsor
Cantonal Hospital of St. Gallen
Collaborators
Heidelberg University, University of Basel, University of Krakau, Department of Visceral surgery
Responsible party
Ignazio Tarantino (M.D., Cantonal Hospital of St. Gallen) — Principal investigator
First posted
Sep 18, 2007
Start date
Dec 1, 2005
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Sep 13, 2018

Study contacts

Andreas Zerz, MD
principal investigator · Cantonal Hospital St. Gallen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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