Transanal Endoscopic Microsurgery Versus Endoscopic Submucosal Dissection For Large Rectal Adenomas

Summary

Objective: Recent non-randomized studies suggest that extended endoscopic submucosal dissection (ESD) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, ESD might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, ESD appears to be associated with fewer complications. In a randomized trial we will compare the cost-effectiveness and cost-utility of TEM and ESD for the resection of large rectal adenomas.

Study design: 15 centers will participate in this multicenter randomized trial comparing TEM versus ESD.

Study population: Patients with a large rectal adenoma (≥2cm), located between 2 and 15 cm from the anal verge. Invasive cancer is excluded by histopathology and endoscopic ultrasonography. Patients must be in a health condition that permits general anesthesia.

Interventions: Patients will be randomized between

a. TEM: under general anesthesia b. ESD under sedation

1. a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.
2. an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.

Primary Endpoint: incidence of recurrence at 12 months

Secondary Endpoints:

morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention) anorectal function. disease specific and general quality of life; number of days not spent in hospital from initial treatment until 2 years afterwards; adenoma

Sample size: Assuming a comparable baseline recurrence rate for TEM and ESD of 6% and considering an upper limit of 10% for ESD to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 60 patients are needed per group. These numbers provide sufficient power to reveal relevant differences in expected morbidity and in number of days not spent in hospital.

Economic evaluation: A cost-effectiveness and cost-utility analysis of ESD against TEM for large rectal adenomas from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as primary outcome measures.

Conditions

• RECTAL NEOPLASMS

Interventions

PROCEDURE

TEM - Transanal Endoscopic Microsurgery

TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.

PROCEDURE

ESD - Endoscopic Submucosal Dissection

an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.

Sponsors & Collaborators

• European Association for Endoscopic Surgery

  lead OTHER

Principal Investigators

• Mario Morino, Prof of Surgery · University of Torino

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Italy

Study Locations