EMR-C VS EMR-S in Colonic Lateral Spreading Tumors Treatment (LST)

NCT03498664 | Unknown DMC

• 1 other identifier: 90/2014
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

"Lateral Spreading Tumors" (LSTs) are dysplastic lesions whose protrusion within the lumens the colon is not more than twice as compared to the surrounding non-dysplastic mucosa. They can be divided into two groups: Granular type (LST-G) and Non Granular type (LST-NG) Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are currently the most used techniques to resect this type of lesions. Compared to other methods of tissue ablation, EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto ("en bloc") EMR is currently the most used technique for removal of LST, but for lesions of ≥ 30 mm the resection is performed "piecemeal", i.e. fragmentary. This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion. Colonic EMR (EMR-S) is usually performed using a polypectomy snare, after lifting the lesion from the underlying layers with a submucosal injection of liquid (EMR standard or "inject-and-cut"). The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope ("cap-assisted EMR" - EMR-C) is almost exclusively used for the treatment of gastric and esophageal lesions. Its use for lesions of the colon and duodenum has been reported in limited experiences The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic LST-G and LST-NG, comparing it with EMR-S.

Conditions

Endoscopic Mucosal Resection

Keywords

EMR-C; EMR-S; LST

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with residual lesions within 12 months.

  Patients with non invasive lesions will undergo follow-up colonoscopies at 3, 6, 12 months and thereafter annually after both EMR-C and EMR-S.. The presence of adenomatous tissue endoscopically visible at follow-up colonoscopies within the first year from EMR will be considered as residual lesion.

  within 12 months

• Proportion of patients with recurrence at 12 months.

  The presence of adenomatous tissue endoscopically visible after two previous negative colonoscopies will be defined as recurrence. "

  at 12 months

Secondary Outcomes (1)

• Proportion of patients with early complications within 48 hours and late complications after 48 hours from both endoscopic procedures.

  at the time of the procedure, within 48 hours, within 12 months

Study Arms (2)

EMR-C group

EXPERIMENTAL

A plastic cap for mucosectomy (MH-597, Olympus Optical Co., Ltd, Tokyo, Japan) with an outer diameter of 17 mm and a length of 15 mm will be preloaded on the tip of the colonoscope. Inside the distal end of the cap there is a gutter which positions the opened polypectomy snare. After submucosal injection, the cap will be applied against the lesion which will be aspirated by "controlled suction", avoiding excessive protrusion of tissue in order not to trap the muscular layer. The tissue will then be gripped with the snare and resection will be performed. A specific polypectomy snare which can be adapted into the gutter of the cap will be used (SD-221U-25, Olympus Optical Co., Ltd, Tokyo, Japan).

Device: cap for mucosectomy

EMR-S group

ACTIVE COMPARATOR

The resection will be performed using a standard polypectomy snare, which diameter will be chosen according to the size of the lesion, after lifting the lesion from the underlying layers with a submucosal injection of liquid.

Device: standard snare for polypectomy

Interventions

cap for mucosectomy DEVICE

endoscopic mucosal resection of colonic lesions with a plastic cap for mucosectomy

EMR-C group

standard snare for polypectomy DEVICE

endoscopic mucosal resection of colonic lesions with standard inject and cut mucosectomy

EMR-S group

Eligibility Criteria

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

You may qualify if:

• Patients ≥18 years Colonic LST-G/NG () ≥ 30 mm in size. Patients able to undergo all follow up procedures as indicated in the protocol and to provide written informed consent, at least 48 hours before the intervention (reasoned consent).

You may not qualify if:

• Presence of sessile polyps Non polypoid lesions 0-III according to Paris Classification Lesions with suspicion of malignancy (rigidity, non-lifting lesions, mucosal fragility, ulceration) Patients unable to provide informed consent Patients with coagulopathy and INR \>1.5 (not corrected with replacement therapy, such as enoxaparin).
• Patients who have undergone previous attempt of lesion resection (residual disease, local recurrence).
• Patients with histological diagnosis of submucosal invading neoplasia who will be sent to surgery and excluded from follow-up.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead
• Azienda USL 1 Imperiese: collaborator
• Azienda Ospedaliera Niguarda Cà Granda: collaborator

Study Sites (1)

AOUSenese

Siena, 53100, Italy

RECRUITING

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Study Officials

• Mario Marini, MD

  Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy.

  PRINCIPAL INVESTIGATOR

• Massimo Conio, MD

  ASL 1 imperiese

  STUDY CHAIR

Central Study Contacts

Antonella De Ceglie, MD

CONTACT

+393391332951; adeceglie@libero.it

Mario Marini, MD

CONTACT

+393494789809; mariomarini.m@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director of Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy.

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 17, 2018
• Study Start: March 15, 2018
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)