Glue Application in the Treatment of Low-Output Fistulas

NCT01828892 | Unknown DMC

• 1 other identifier: 20120819
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 management of patients with low-output volume ECFs.

Conditions

Low-output External Gastrointestinal Fistula

Keywords

Autologous platelet rich fibrin glue; Enterocutaneous fistulas; Single low output GI fistulas

Outcome Measures

Primary Outcomes (1)

• Closure rates up to 14 days

  The fraction of patients with complete closure of fistula during 14 days

  14 days

Secondary Outcomes (1)

• Number of adverse events

  Participants will be followed for at least 180 days

Other Outcomes (1)

• Economic outcome

  From fistula onset to the end of treatment, which is at least 180 days

Study Arms (3)

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.

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.

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.

Procedure: Endoscopy exploration and glue application; Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin); Dietary Supplement: Nutrition support

Interventions

Endoscopy exploration and glue application PROCEDURE

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.

Commercial FG; PRFG treatment

Endoscopy exploration PROCEDURE

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.

Control

Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) DRUG

Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain

Also known as: ceftazidime, cefotaxime, or meropenem, with or without vancomycin

Commercial FG; Control; PRFG treatment

Nutrition support DIETARY_SUPPLEMENT

Nutritional replacement and bowel rest via enteral or parenteral nutrition

Commercial FG; Control; PRFG treatment

Eligibility Criteria

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

You may qualify if:

• Patients with a single tubular ECF
• Low output volume (\<200 ml/24h)
• Tract length \>2cm
• Tract diameter \< 1cm

You may not qualify if:

• Cancer-infiltrated fistula
• Abscess
• Foreign bodies
• Distal bowel obstruction
• Inflammatory Bowel Disease

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 26445823 DERIVED

MeSH Terms

Conditions

Intestinal Fistula

Interventions

Anti-Bacterial Agents; Ceftazidime; Cefotaxime; Meropenem; Nutrition Therapy

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephacetrile; Thienamycins; Carbapenems; Therapeutics

Study Officials

• Jianan Ren, MD

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianan Ren, MD

CONTACT

862580860108; jiananr@gmail.com

XIUWEN WU

CONTACT

862580860008; xiuwenwoo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of department of surgery, Jinling Hospital

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 11, 2013
• Study Start: March 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

CN (1)