Radiation InjuriesPhase 4NCT00725244
Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias
A Phase 4 study testing Bipolar eletrocoagulation and Argon Plasma Coagulation in people with Radiation Injuries and Telangiectasis, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Radiation Injuries, Telangiectasis
- What is being tested?
- Bipolar eletrocoagulation and Argon Plasma Coagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2005to Jul 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- prior endoscopic treatment
- rectal or colonic surgery
- stenosis rectal
- rectal bleeding before radiotherapy
- severe cardiac disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University Of São Paulo - Gastroenterology
São Paulo, São Paulo
About this study
Official title: A Randomized Prospective Study of Endoscopy Bipolar Eletrocoagulation and Argon Plasma Coagulation 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).
Read more
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.
Read the 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
- Being tested
- Bipolar eletrocoagulation, Argon Plasma Coagulation
- Keywords
- Radiation Injuries, Telangiectasis, Bipolar Eletrocoagulation, Argon Plasma Coagulation
- Medical subject headings
- Radiation Injuries, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar eletrocoagulationDevice
Also called - bipolar probe, - bipolar electrocoagulation
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.
Argon Plasma CoagulationDevice
Also called Argon Laser, Argonio
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Argon Plasma Coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve of rectal bleeding
Measured: 6 months
Secondary outcomes (1)
Complications of each group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startMay 2005
- Primary completionNov 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Angelo Ferrari, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725244
- Sponsor's protocol ID
- 556/05
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study of Endoscopy Bipolar Eletrocoagulation and Argon Plasma Coagulation of Chronic Rectal Bleeding From Radiation Telangiectasias
- ClinicalTrials.gov ID
- NCT00725244
- Acronym / sponsor ID
- 556/05
- Conditions
- Radiation Injuries, Telangiectasis
- Keywords
- Radiation Injuries, Telangiectasis, Bipolar Eletrocoagulation, Argon Plasma Coagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Bipolar eletrocoagulationBipolar 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 | Active comparator | Device: Argon Plasma CoagulationArgon 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. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- prior endoscopic treatment
- rectal or colonic surgery
- stenosis rectal
- rectal bleeding before radiotherapy
- severe cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar eletrocoagulationAlso: - bipolar probe, - bipolar electrocoagulationBipolar 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 | 1 |
| Argon Plasma CoagulationAlso: Argon Laser, ArgonioArgon 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 | 2 |
Primary outcome
Improve of rectal bleeding
Time frame: 6 months
1 secondary outcome
Complications of each group
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Ferrari, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bipolar eletrocoagulation and Argon Plasma Coagulation in people with Radiation Injuries and Telangiectasis, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve of rectal bleeding (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.