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Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

C

Cantonal Hospital of St. Gallen

Status

Terminated

Conditions

Rectal Neoplasms

Treatments

Procedure: endoscopic posterior mesorectal resection

Study type

Interventional

Funder types

Other

Identifiers

NCT00531297
EKSG 05/072/2B

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Treatment arm
Experimental group
Description:
endoscopic posterior mesorectal resection
Treatment:
Procedure: endoscopic posterior mesorectal resection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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