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

NCT00725244 | Completed Phase 4 DMC

• 1 other identifier: 556/05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Injuries; Telangiectasis

Keywords

Radiation Injuries; Telangiectasis; Bipolar Eletrocoagulation; Argon Plasma Coagulation

Outcome Measures

Primary Outcomes (1)

• Improve of rectal bleeding

  6 months

Secondary Outcomes (1)

• Complications of each group

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Device: Bipolar eletrocoagulation

2

ACTIVE COMPARATOR

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.

Device: Argon Plasma Coagulation

Interventions

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.

Also known as: - bipolar probe, - bipolar electrocoagulation

1

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.

Also known as: Argon Laser, Argonio

2

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University Of São Paulo - Gastroenterology

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Radiation Injuries; Telangiectasis

Interventions

Argon Plasma Coagulation; Lasers, Gas

Condition Hierarchy (Ancestors)

Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Angelo Ferrari, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: May 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: July 1, 2008
• Last Updated: October 17, 2008

Record last verified: 2008-07

Locations

BR (1)