Transanal Endoscopic Microsurgery Versus Endoscopic Submucosal Dissection For Large Rectal Adenomas (TEMENDO)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by European Association for Endoscopic Surgery
Sponsor:
Information provided by (Responsible Party):
Alberto Arezzo, European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier:
NCT01023984
First received: December 1, 2009
Last updated: April 26, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
RECTAL NEOPLASMS
Procedure: TEM - Transanal Endoscopic Microsurgery
Procedure: ESD - Endoscopic Submucosal Dissection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by European Association for Endoscopic Surgery:

Primary Outcome Measures:
  • Incidence of recurrence at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Anorectal function [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Disease specific and general quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of days not spent in hospital from initial treatment until 2 years afterwards [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TEM - Transanal Endoscopic Microsurgery
TEM under general anesthesia
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.
Active Comparator: ESD - Endoscopic Submucosal Dissection
ESD under sedation
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with a large non-pedunculated rectal adenoma (sessile or flat) with a largest diameter of ≥2 cm (estimated by an opened resection snare of 20 or 30 mm).
  2. The lower and upper borders of the adenoma are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
  3. Biopsies of the lesion did not show malignant neoplastic tissue on histopathological evaluation; only lesions with low or high grade dysplasia are suitable for inclusion.
  4. During flexible video endoscopy there are no signs of endoscopic suspicion for submucosal invasive cancer (Kudo pit pattern type V; excavated/depressed type morphology; fold convergence; or large smooth nodule >1 cm in a flat lesion) (33). In case of doubt, patients will undergo EUS as described at (2).
  5. In case doubt remains after flexible video endoscopy, endoscopic ultrasonography (EUS) of the rectal adenoma should exclude invasion into the submucosal layer and exclude pathological lymphadenopathy (lymph nodes >1 cm). When pathological lymph nodes are present, fine needle aspiration will be performed to exclude lymph node metastasis (N+ disease).
  6. If not performed already, total colonoscopy will be done to detect and remove all synchronous colonic adenomas or cancers first. Cecal intubation must be confirmed by identification of the appendiceal orifice and ileocecal valve.
  7. The general health condition of the patient permits general anesthesia (ASA- classification I-III).
  8. Absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
  9. Patient age of 18 years or older.

Exclusion Criteria:

  1. Preoperative histologically detected malignancy
  2. Previous anorectal surgery
  3. Contraindications to general anaesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023984

Contacts
Contact: Mario Morino, Prof of Surgery +390116313149 mario.morino@unito.it
Contact: Alberto Arezzo +390116336641 alberto.arezzo@unito.it

Locations
Italy
University of Torino Recruiting
Torino, TO, Italy, 10126
Contact: Alberto Arezzo, Assistant Professor of Surgery    +393358378243    alberto.arezzo@mac.com   
Sub-Investigator: Mario Morino, Prof of Surgery         
Principal Investigator: Alberto Arezzo, Assistant Professor of Surgery         
Sponsors and Collaborators
European Association for Endoscopic Surgery
Investigators
Study Chair: Mario Morino, Prof of Surgery University of Torino
  More Information

Publications:
Responsible Party: Alberto Arezzo, Assistant Professor of Surgery, European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier: NCT01023984     History of Changes
Other Study ID Numbers: EAES-2
Study First Received: December 1, 2009
Last Updated: April 26, 2014
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by European Association for Endoscopic Surgery:
RECTAL NEOPLASMS

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014