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

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ClinicalTrials.gov Identifier: NCT03498664
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Azienda USL 1 Imperiese
Azienda Ospedaliera Niguarda Cà Granda
Information provided by (Responsible Party):
Mario Marini, Azienda Ospedaliera Universitaria Senese

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.


Condition or disease Intervention/treatment Phase
Endoscopic Mucosal Resection Device: cap for mucosectomy Device: standard snare for polypectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Cap-assisted" Endoscopic Mucosal Resection vs Standard "Inject and Cut" Endoscopic Mucosal Resection for Large Colonic "Lateral Spreading Tumors" Treatment: a Randomized Multicentric Study.
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: EMR-C group

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

Active Comparator: EMR-S group
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
endoscopic mucosal resection of colonic lesions with standard inject and cut mucosectomy




Primary Outcome Measures :
  1. Proportion of patients with residual lesions within 12 months. [ Time Frame: 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.


  2. Proportion of patients with recurrence at 12 months. [ Time Frame: at 12 months ]
    The presence of adenomatous tissue endoscopically visible after two previous negative colonoscopies will be defined as recurrence. "


Secondary Outcome Measures :
  1. Proportion of patients with early complications within 48 hours and late complications after 48 hours from both endoscopic procedures. [ Time Frame: at the time of the procedure, within 48 hours, within 12 months ]

    Complications are defined as:

    intraprocedural early: within 48 hours; late: after 48 hours from the endoscopic procedure;

    Type of complications:

    Bleeding (intraprocedural, loss of blood from rectum; Perforation (documented with the presence of free air in abdomen by RX and/or CT); Post polipectomy syndrome (abdominal pain with or without fever, without any free air in abdomen reported by radiological investigations)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498664


Contacts
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Contact: Antonella De Ceglie, MD +393391332951 adeceglie@libero.it
Contact: Mario Marini, MD +393494789809 mariomarini.m@libero.it

Locations
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Italy
AOUSenese Recruiting
Siena, Italy, 53100
Contact: Mario Marini, MR    +393494789809    mariomarini.m@libero.it   
Sub-Investigator: Massimo Conio, MD         
Sub-Investigator: Antonella De Ceglie, MD         
Sub-Investigator: Raffaele Manta, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese
Azienda USL 1 Imperiese
Azienda Ospedaliera Niguarda Cà Granda
Investigators
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Principal Investigator: Mario Marini, MD Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy.
Study Chair: Massimo Conio, MD ASL 1 imperiese

Publications of Results:

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Responsible Party: Mario Marini, MD, Director of Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy., Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT03498664    
Other Study ID Numbers: 90/2014
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Marini, Azienda Ospedaliera Universitaria Senese:
EMR-C; EMR-S; LST