Endoscopic Mucosal Resection Clinical Trial
— LSTOfficial 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.
"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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 15, 2019 |
Est. primary completion date | September 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | AOUSenese | Siena |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Senese | Azienda Ospedaliera Niguarda Cà Granda, Azienda USL 1 Imperiese |
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Proportion of patients with early complications within 48 hours and late complications after 48 hours from both endoscopic procedures. | 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) |
at the time of the procedure, within 48 hours, within 12 months |
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