Skip to main content
OpenTrials
Completed

NCT Number: NCT00725244

Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias

Aim:

To compare the efficacy, safety and number of sessions of bipolar eletrocoagulation (BEC) and argon plasma coagulation (APC) in the management of the bleeding telangiectasias from chronic radiation coloproctopathy (CRCP).

Methods:

Thirty patients with active bleeding from telangiectasias were enrolled in two groups (15 BEC and 15 APC) and classified according of Saunders score. BEC settings were 50 W and APC settings were 40 W and 1.0 l/min. Colonoscopy was the first exam to rule out synchronous lesions and follow-up was performed with sigmoidoscopies. Clinical cure was defined as cessation of bleeding and endoscopic cure was determined by absence of telangiectasias. Failure was defined whenever more than 7 sessions or other therapy was necessary.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiation Injuries Cardiovascular Diseases Telangiectasis Vascular Diseases Wounds and Injuries

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University Of São Paulo - Gastroenterology

São Paulo, Brazil

About this study

Thirty patients with active and chronic hematochezia from radiation telangiectasias were randomized in two groups :

  • fifteen patients in group 1- bipolar eletrocoagulation (BE) and
  • fifteen in group 2 - argon plasma coagulation(APC). For inclusion in the study, all patients were required to have active (at least one episode last week) and chronic (persist or appear 6 months after the conclusion of radiotherapy) rectal bleeding. Between May 2005 and April 2008, patients were treated and followed at the Endoscopy Unit in the São Paulo Hospital (UNIFESP).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • active (at least one episode last week) and chronic (persist or appear 6 months after the conclusion of radiotherapy) rectal bleeding.
  • previous radiotherapy at least 6 months ago
  • presence of colonic or rectal telangiectasias
  • patients that agreed to participate of the study and signed the Term of Free Consent and Cleared

Exclusion criteria

  • prior endoscopic treatment
  • rectal or colonic surgery
  • stenosis rectal
  • rectal bleeding before radiotherapy
  • severe cardiac disease

Treatment and study plan

Bipolar eletrocoagulation

Device

Bipolar Eletrocoagulation was performed with a high-frequency electrosurgical generator (ERBE® ICC 200 Eletromedizin, Tubingen, Germany), using Gold probe (Wilson- Cook®) with 7 Fr diameter and 300 cm length. The power setting was 50 W. Coagulation of each telangiectasia was achieved with the probes by applying light pressure directly on the telangiectasia.

Other names: - bipolar probe, - bipolar electrocoagulation

Argon plasma coagulation

Device

Argon plasma coagulation was delivered using a "spray-painting" technique, with short applications at 40 W power with a gas flow of 1.0l per minute. APC equipment was an argon delivery unit (ERBE® ICC 300) coupled a high frequency surgery unit (ERBE® ICC 200). Only the end-firing probe with 2.3 mm and 220 cm length was used. The probe was purged with argon, tested and passed though the endoscope until it extends approximately 1 cm from the tip. The probe was hold just above the mucosal surface and the contact was avoided. During the procedure periodic suction was made to prevent over-distention with gas and consequently patient discomfort.

Other names: Argon Laser, Argonio

Primary outcomes

  1. Improve of rectal bleeding

    Time frame: 6 months

Secondary outcomes

  1. Complications of each group

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

A Randomized Prospective Study of Endoscopy Bipolar Eletrocoagulation and Argon Plasma Coagulation of Chronic Rectal Bleeding From Radiation Telangiectasias

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jul 30, 2008
Registry last updated
Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.