The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps

NCT01565993 | Terminated Results

• 1 other identifier: EQCLIPS
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding

Conditions

Postpolypectomy Bleeding

Outcome Measures

Primary Outcomes (1)

• The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)

  In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called "complications", despite their severity and clinical significance

  Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding

Secondary Outcomes (1)

• Difficult to Place the Clip

  During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)

Study Arms (2)

Hemoclip

ACTIVE COMPARATOR

In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop

Device: Hemoclip

Conventional Polipectomy

ACTIVE COMPARATOR

In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique

Device: Conventional Polipectomy

Interventions

Hemoclip DEVICE

A rotatable clip-fixing device "Quickclip 2" standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm

Hemoclip

Conventional Polipectomy DEVICE

Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection

Conventional Polipectomy

Eligibility Criteria

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

You may qualify if:

• Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen
• Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).

You may not qualify if:

• Patients younger than 18 years of age
• Patients with a platelet count of less than 50000, INR larger than 1.5
• Patients who refused to give their informed consent.

Sponsors & Collaborators

• Hospital Severo Ochoa: lead

Study Sites (1)

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Related Publications (2)

• Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Oct;2(4):183-188. doi: 10.4161/jig.23741. Epub 2012 Oct 1.

  PMID: 23687606 DERIVED

• Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Apr;2(2):99-104. doi: 10.4161/jig.22210. Epub 2012 Apr 1.

  PMID: 23687598 DERIVED

Limitations and Caveats

Not to reach the sample size established previously in the initial design, implies bias and decreases the strength of the study.

Results Point of Contact

• Title: Dra Elvira Quintanilla
• Organization: Hospital Universitario Severo Ochoa

elviramquintanilla@hotmail.com

34 914818000

Study Officials

• Elvira M Quintanilla, MD

  Hospital Universitario Severo Ochoa

  PRINCIPAL INVESTIGATOR

• Luis R Rábago, PhD

  Hospital Universitario Severo Ochoa

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: July 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 25, 2012
• Results First Posted: May 25, 2012

Record last verified: 2012-04

Locations

ES (1)