Low-output External Gastrointestinal FistulaGlue-sealingNCT01672593
Glue Sealing for Patients With Low-Output ECFs
A study testing Endoscopy exploration and glue application, Anti-Bacterial Agents and Nutrition support in people with Low-output External Gastrointestinal Fistula, run by Jinling Hospital, China at 1 site in China.
Trial summary
Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low-output External Gastrointestinal Fistula
- What is being tested?
- Endoscopy exploration and glue application, Anti-Bacterial Agents and Nutrition support
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Dec 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a single tubular ECF
- Low output volume (<200 ml/24h)
- Tract length >2cm
- Tract diameter < 1cm
Who cannot join
- Cancer-infiltrated fistula
- Abscess
- Foreign bodies
- Distal bowel obstruction
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Surgery, Jinling Hospital
Nanjing, Jiangsu, 210002
Jianan Ren, M.D., 862580860108, jiananr@gmail.com
About this study
Official title: A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs
Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.
Read the detailed description
- This is a prospective, randomized, single-centered study clinical, safety and economic outcome of ECFs patients.
- Subjects are randomized to one of 2 groups:
- Group 1: Autologous PRFG-treatment (PRFG + SOC)
- Group 2: Commercial FG-treatment (Bioseal® + SOC)
- Study will include three phases:
- Phase 1: Screening, consent and enrollment
- Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
- Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.
- Being tested
- Endoscopy exploration and glue application, Anti-Bacterial Agents, Nutrition support, PRFG preparation
- Keywords
- Autologous platelet rich fibrin glue;, Enterocutaneous fistulas;, Single low output GI fistulas;
- Medical subject headings
- Intestinal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy exploration and glue applicationProcedure or surgery
A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device. Upon injection, two components, fibrinogen and thrombin, were mixed together in the mixing reservoir and yield a gelatin-like glue. This procedure was repeated in patients up to 3 times within 14-day FG treatment period.
Anti-Bacterial AgentsDrug
Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
Nutrition supportDietary supplement
Nutritional replacement and bowel rest via enteral or parenteral nutrition.
PRFG preparationProcedure or surgery
As described in our previous work, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the PRFG group and then frozen at -20°C for storage.
| Study group | Role | What they receive |
|---|---|---|
| PRFG treatment | Experimental | As described in our previous study, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the autologous PRFG(platelet-rich fibrin glue) group and then frozen at -20°C for storage. Prior to application, frozen cryoprecipitate and thrombin stored were thawed in a 37°C water bath. Aminomethylbenzoic Acid (1ml: 1mg, Sigma-Aldrich, St Louis, MO) was added into the cryoprecipitate in the volume ratio of 1:10. Receives: Procedure: Endoscopy exploration and glue application; Drug: Anti-Bacterial Agents; Dietary Supplement: Nutrition support; Procedure: PRFG preparation |
| Bioseal treatment | Active comparator | The commercial fibrin sealants used in the study were purchased from Guangzhou Bioseal Biotech Co. Ltd, Guangzhou, China. Upon application, two components, fibrinogen and thrombin, were placed separately in two syringes which were joined by a Y-shaped connector. The trunk of the Y-shaped connecter was connected to a single lumen catheter. Receives: Procedure: Endoscopy exploration and glue application; Drug: Anti-Bacterial Agents; Dietary Supplement: Nutrition support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Closure time (defined as the interval between the day of enrollment and day of fistula closure), Closure rate up to 14 days, Closure rate up to 180 days, Fistula recurrence rate
Measured: 14 days
Secondary outcomes (1)
Safety outcome
Incidence of adverse events and severe adverse events up to 180 days (defined as an event that was fatal or life-threatening, led to additional hospitalization or disability, or required an intervention to prevent one of these outcomes)
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-output External Gastrointestinal FistulaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Ren, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672593
- Sponsor's protocol ID
- 20120818
- Acronym
- Glue-sealing
- Status last verified
- Mar 2014
- First submitted
- 19 Aug 2012
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs
- ClinicalTrials.gov ID
- NCT01672593
- Acronym / sponsor ID
- Glue-sealing / 20120818
- Keywords
- Autologous platelet rich fibrin glue;, Enterocutaneous fistulas;, Single low output GI fistulas;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Aug 2012 (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.
Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.
Detailed description
- This is a prospective, randomized, single-centered study clinical, safety and economic outcome of ECFs patients.
- Subjects are randomized to one of 2 groups:
- Group 1: Autologous PRFG-treatment (PRFG + SOC)
- Group 2: Commercial FG-treatment (Bioseal® + SOC)
- Study will include three phases:
- Phase 1: Screening, consent and enrollment
- Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
- Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRFG treatment | Experimental | Procedure: Endoscopy exploration and glue application, Drug: Anti-Bacterial Agents, Dietary Supplement: Nutrition support, Procedure: PRFG preparationAs described in our previous study, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the autologous PRFG(platelet-rich fibrin glue) group and then frozen at -20°C for storage. Prior to application, frozen cryoprecipitate and thrombin stored were thawed in a 37°C water bath. Aminomethylbenzoic Acid (1ml: 1mg, Sigma-Aldrich, St Louis, MO) was added into the cryoprecipitate in the volume ratio of 1:10. |
| Bioseal treatment | Active comparator | Procedure: Endoscopy exploration and glue application, Drug: Anti-Bacterial Agents, Dietary Supplement: Nutrition supportThe commercial fibrin sealants used in the study were purchased from Guangzhou Bioseal Biotech Co. Ltd, Guangzhou, China. Upon application, two components, fibrinogen and thrombin, were placed separately in two syringes which were joined by a Y-shaped connector. The trunk of the Y-shaped connecter was connected to a single lumen catheter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a single tubular ECF
- Low output volume (<200 ml/24h)
- Tract length >2cm
- Tract diameter < 1cm
Key exclusion criteria (5 listed)
- Cancer-infiltrated fistula
- Abscess
- Foreign bodies
- Distal bowel obstruction
- Inflammatory bowel 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 |
|---|---|---|
| Endoscopy exploration and glue applicationA forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device. Upon injection, two components, fibrinogen and thrombin, were mixed together in the mixing reservoir and yield a gelatin-like glue. This procedure was repeated in patients up to 3 times within 14-day FG treatment period. | Procedure or surgery | Bioseal treatment, PRFG treatment |
| Anti-Bacterial AgentsAntibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain. | Drug | Bioseal treatment, PRFG treatment |
| Nutrition supportNutritional replacement and bowel rest via enteral or parenteral nutrition. | Dietary supplement | Bioseal treatment, PRFG treatment |
| PRFG preparationAs described in our previous work, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the PRFG group and then frozen at -20°C for storage. | Procedure or surgery | PRFG treatment |
Primary outcome
Clinical outcome
Time frame: 14 days
Closure time (defined as the interval between the day of enrollment and day of fistula closure), Closure rate up to 14 days, Closure rate up to 180 days, Fistula recurrence rate
1 secondary outcome
Safety outcome
Time frame: up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy exploration and glue application, Anti-Bacterial Agents and Nutrition support in people with Low-output External Gastrointestinal Fistula, run by Jinling Hospital, China at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 11 Mar 2014. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianan Ren, MD (862580860108, jiananr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 14 days). 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 11 Mar 2014.