Transanal Endoscopic Microsurgery Versus Endoscopic Submucosal Dissection For Large Rectal Adenomas

NCT01023984 | Withdrawn Phase 4 DMC

• 1 other identifier: EAES-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

RECTAL NEOPLASMS

Keywords

RECTAL NEOPLASMS

Outcome Measures

Primary Outcomes (1)

• Incidence of recurrence at 12 months

  12 months

Secondary Outcomes (4)

• Morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention)

  24 months

• Anorectal function

  12 months

• Disease specific and general quality of life

  12 months

• Number of days not spent in hospital from initial treatment until 2 years afterwards

  12 months

Study Arms (2)

TEM - Transanal Endoscopic Microsurgery

ACTIVE COMPARATOR

TEM under general anesthesia

Procedure: TEM - Transanal Endoscopic Microsurgery

ESD - Endoscopic Submucosal Dissection

ACTIVE COMPARATOR

ESD under sedation

Procedure: ESD - Endoscopic Submucosal Dissection

Interventions

TEM - Transanal Endoscopic Microsurgery PROCEDURE

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.

TEM - Transanal Endoscopic Microsurgery

ESD - Endoscopic Submucosal Dissection PROCEDURE

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.

ESD - Endoscopic Submucosal Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• The lower and upper borders of the adenoma are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
• 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).
• 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).
• 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.
• The general health condition of the patient permits general anesthesia (ASA- classification I-III).
• Absence of non-correctable coagulopathy (international normalized ratio \>1,5, or platelet count \<90 × 109/l).
• Patient age of 18 years or older.

You may not qualify if:

• Preoperative histologically detected malignancy
• Previous anorectal surgery
• Contraindications to general anaesthesia

Sponsors & Collaborators

• European Association for Endoscopic Surgery: lead

Study Sites (1)

University of Torino

Torino, TO, 10126, Italy

Location

Related Publications (3)

• Repici A, Conio M, De Angelis C, Sapino A, Malesci A, Arezzo A, Hervoso C, Pellicano R, Comunale S, Rizzetto M. Insulated-tip knife endoscopic mucosal resection of large colorectal polyps unsuitable for standard polypectomy. Am J Gastroenterol. 2007 Aug;102(8):1617-23. doi: 10.1111/j.1572-0241.2007.01198.x. Epub 2007 Mar 31.

  PMID: 17403075 BACKGROUND

• Bretagnol F, Merrie A, George B, Warren BF, Mortensen NJ. Local excision of rectal tumours by transanal endoscopic microsurgery. Br J Surg. 2007 May;94(5):627-33. doi: 10.1002/bjs.5678.

  PMID: 17335125 BACKGROUND

• Bach SP, Hill J, Monson JR, Simson JN, Lane L, Merrie A, Warren B, Mortensen NJ; Association of Coloproctology of Great Britain and Ireland Transanal Endoscopic Microsurgery (TEM) Collaboration. A predictive model for local recurrence after transanal endoscopic microsurgery for rectal cancer. Br J Surg. 2009 Mar;96(3):280-90. doi: 10.1002/bjs.6456.

  PMID: 19224520 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mario Morino, Prof of Surgery

  University of Torino

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: January 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

IT (1)