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

NCT ID: NCT00725244

Last Updated: 2008-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-07-31

Brief Summary

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.

Detailed Description

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).

Conditions

Radiation Injuries; Telangiectasis

Keywords

Radiation Injuries; Telangiectasis; Bipolar Eletrocoagulation; Argon Plasma Coagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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.

Group Type: ACTIVE_COMPARATOR

Bipolar eletrocoagulation

Intervention Type: 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.

2

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.

Group Type: ACTIVE_COMPARATOR

Argon Plasma Coagulation

Intervention Type: 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.

Interventions

Bipolar eletrocoagulation

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.

Intervention Type: DEVICE

Argon Plasma Coagulation

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.

Intervention Type: DEVICE

Other Intervention Names

- bipolar probe; - bipolar electrocoagulation; Argon Laser; Argonio

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of São Paulo

Principal Investigators

Angelo Ferrari, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

Federal University Of São Paulo - Gastroenterology

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

556/05

Identifier Type: -

Identifier Source: org_study_id