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Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

Efficacy of Cyanoacrylate in the Prevention of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Polyps.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04308824
Enrollment
76
Registered
2020-03-16
Start date
2019-02-02
Completion date
2022-04-02
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Polyp

Brief summary

Endoscopic resection of large non-pedunculated adenomas is most often performed using the 'lift-and-cut' endoscopic mucosal resection (EMR) technique. This endoscopic technique has a relatively low technical complexity and short-duration and is commonly considered a safe and reliable surgical option, nevertheless several adverse events can occur during or after this procedure. One of the most frequent late complication is the post-procedural bleeding occurring up to 30 days post-polypectomy, which often requires emergency hospitalization and re-intervention. Endoscopic hemostasis of active post procedure bleeding can be achieved using prophylactic clips. Recently, the use on sprayable hemostatic agents have been introduced in the gastrointestinal endoscopical practice. Cyanoacrylate is a liquid tissue adhesive that has been proved to be of some utility in the endoscopic management of gastrointestinal variceal bleeding. In this study the investigators aim to compare the rate of postoperative bleeding between two groups of patients with large colorectal polyps. In the first group it will be performed a prophylactic clipping after the polypectomy and in the other group it will be used cyanoacrylate after clipping.

Detailed description

Introduction of endoscopic removal of colorectal polyps in the clinical practice has profoundly contributed to the modified epidemiology of colorectal cancer in western countries by reducing its incidence and mortality through a primary prevention. Endoscopic removal of polyps can be carried out using several techniques depending on their morphology, size, location along the colon and the expertise of the endoscopist. Endoscopic resection of large non-pedunculated adenomas is most often performed using the 'lift-and-cut' endoscopic mucosal resection (EMR) technique. This endoscopic technique has a relatively low technical complexity and short-duration and is commonly considered a safe and reliable surgical option, nevertheless several adverse events can occur during or after this procedure, even in experienced hands. One of the most frequent late complication is the post-procedural bleeding (PPB) occurring up to 30 days post-polypectomy, which often requires emergency hospitalization and re-intervention (by repeated endoscopy, angiography, or even major surgery). The frequency of PPB after EMR of colonic polyps is reported between 0.4 % and 7 % depending on patients' co-morbidities and medications, location and size of the polyps and endoscopic technique. Endoscopic hemostasis of active PPB can be achieved using different techniques according to the location and characteristics of the lesion, endoscopist's preference and experience, and device availability. However, the most commonly method used is clipping with or without adrenaline injection. Recently, the use on sprayable hemostatic agents have been introduced in the gastrointestinal endoscopical practice providing a non-traumatic and technically easy method of hemostasis which can be used also in cases of diffuse, multifocal source of bleeding due to ulcers, tumors or post-EMR or in areas difficult to access, such as the lesser curvature of the stomach, posterior wall of the duodenal bulb. Cyanoacrylate is a liquid tissue adhesive that has been proved to be of some utility in the endoscopic management of gastrointestinal variceal bleeding. In this study, we will compare the short and mid-term results of the endoscopic use of N-butyl-2-cyanoacrylate associated with methacryloxysulfolane in the prevention of delayed bleeding after EMR of large colorectal polyps.

Interventions

a single clip will be placed in every case of polypectomy for large colorectal polyps

OTHERnebulization of glue

After clipping, a cyanoacrilate glue will be nebulized using a spray catheter

Sponsors

Societa Italiana di Chirurgia ColoRettale
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* peduncolated or flat polyps \> 2cm of the colon * anticoagulant therapy interrupted 5 days before the procedure

Exclusion criteria

* Coagulation disorders * pregnancy * malignant appearing polyps

Design outcomes

Primary

MeasureTime frameDescription
Early bleeding24 hoursBleeding is defined as early if occurrs within 48h after the procedure
Delayed bleeding2-7 daysBleeding is defined as delayed if occurrs more than 48 hours after the procedure

Countries

Italy

Contacts

Primary ContactDonato Altomare, Prof
donatofrancesco.altomare@uniba.it3397593066
Backup ContactArcangelo Picciariello, MD
arcangelopicciariello@gmail.com+393492185104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026