Low-output External Gastrointestinal FistulaFG-treatmentNCT01828892

Glue Application in the Treatment of Low-Output Fistulas

A study testing Endoscopy exploration and glue application, Endoscopy exploration and Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) in people with Low-output External Gastrointestinal Fistula, run by Jinling Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the… 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, Endoscopy exploration and Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteChina
Study dates: Mar 2014to Dec 2017
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.

Jianan Ren, MD contact

XIUWEN WU contact

China1 site, 1 recruiting

Jinling Hospital
Nanjing, Jiangsu, 210002
Jianan Ren, MD, 862580860108, Jiananr@gmail.com
Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas

Read the detailed description

This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.
Subjects are randomized to one of 3 groups:
Group 1: Autologous PRFG-treatment [PRFG + Standard of care (SOC)]
Group 2: Commercial FG-treatment [FG + Standard of care (SOC)]
Group 3: Control (SOC only)
Study will include three phases:
Phase 1: Screening, consent and enrollment
Phase 2: Patients will receive either PRFG, commercial FG, or SOC 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.

Conditions: Low-output External Gastrointestinal Fistula
Being tested: Endoscopy exploration and glue application, Endoscopy exploration, Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin), Nutrition support
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.
Endoscopy explorationProcedure 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.
Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)Drug
Also called ceftazidime, cefotaxime, or meropenem, with or without vancomycin
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Nutrition supportDietary supplement
Nutritional replacement and bowel rest via enteral or parenteral nutrition

Study groups in NCT01828892
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 PRFG 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: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin); Dietary Supplement: Nutrition support
Control	Sham comparator	Patients in this group only received standard of care when their fistula output < 200ml/24h. Receives: Procedure: Endoscopy exploration; Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin); Dietary Supplement: Nutrition support
Commercial FG	Experimental	Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas. Receives: Procedure: Endoscopy exploration and glue application; Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin); Dietary Supplement: Nutrition support

What is being measured

The primary outcome is the main question the study is designed to answer.

Closure rates up to 14 days
The fraction of patients with complete closure of fistula during 14 days
Measured: 14 days

Secondary outcomes (1)

Number of adverse events
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: Participants will be followed for at least 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Dec 2017

First posted11 Apr 2013 (estimated)
Study startMar 2014
Primary completionJun 2017 (estimated)
Study completionDec 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01828892
Sponsor's protocol ID: 20120819
Acronym: FG-treatment
Status last verified: Jun 2015
First submitted: 1 Apr 2013
Last updated: 10 Jun 2015
Results posted: No
Data monitoring committee: Yes

Publications

Wu X, Ren J, Wang G, Wang J, Wang F, Fan Y, Li Y, Han G, Zhou Y, Song X, Quan B, Yao M, Li J. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial. Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9.
PubMed 26445823

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas
ClinicalTrials.gov ID: NCT01828892
Acronym / sponsor ID: FG-treatment / 20120819
Conditions: Low-output External Gastrointestinal Fistula
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: Mar 2014
Primary completion: Jun 2017 (estimated)
Study completion: Dec 2017 (estimated)
First posted: 11 Apr 2013 (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.

Detailed description

This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.
Subjects are randomized to one of 3 groups:
Group 1: Autologous PRFG-treatment [PRFG + Standard of care (SOC)]
Group 2: Commercial FG-treatment [FG + Standard of care (SOC)]
Group 3: Control (SOC only)
Study will include three phases:
Phase 1: Screening, consent and enrollment
Phase 2: Patients will receive either PRFG, commercial FG, or SOC 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: 3

Arm	Type	Receives
PRFG treatment	Experimental	Procedure: Endoscopy exploration and glue application, Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin), Dietary Supplement: Nutrition supportAs described in our previous study, 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. 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.
Control	Sham comparator	Procedure: Endoscopy exploration, Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin), Dietary Supplement: Nutrition supportPatients in this group only received standard of care when their fistula output < 200ml/24h.
Commercial FG	Experimental	Procedure: Endoscopy exploration and glue application, Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin), Dietary Supplement: Nutrition supportCommercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.

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.	Procedure or surgery	Commercial FG, PRFG treatment
Endoscopy explorationA 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.	Procedure or surgery	Control
Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)Also: ceftazidime, cefotaxime, or meropenem, with or without vancomycinAntibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain	Drug	Commercial FG, Control, PRFG treatment
Nutrition supportNutritional replacement and bowel rest via enteral or parenteral nutrition	Dietary supplement	Commercial FG, Control, PRFG treatment

Primary outcome

Closure rates up to 14 days
Time frame: 14 days
The fraction of patients with complete closure of fistula during 14 days

1 secondary outcome

Number of adverse events
Time frame: Participants will be followed for at least 180 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
Derived from this study: PubMed 26445823Wu X, Ren J, Wang G, Wang J, Wang F, Fan Y, Li Y, Han G, Zhou Y, Song X, Quan B, Yao M, Li J. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial. Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9.

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.

Jianan Ren, MD contact

XIUWEN WU contact

Jianan Ren, MD principal investigator

Jinling Hospital, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 Jun 2015. 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. Some participants in this study may receive a placebo. 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?

Closure rates up to 14 days (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01828892, which also lists 1 linked publication.

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 10 Jun 2015.