Glue Sealing for Patients With Low-Output ECFs

NCT01672593 | Unknown DMC

• 1 other identifier: 20120818
• 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 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.

Conditions

Low-output External Gastrointestinal Fistula

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  14 days

Secondary Outcomes (1)

• Safety outcome

  up to 180 days

Other Outcomes (1)

• Economic outcome

  Upon enrollment, an expected average of 1 year

Study Arms (2)

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.

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.

Procedure: Endoscopy exploration and glue application; Drug: Anti-Bacterial Agents; 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. 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.

Bioseal treatment; PRFG treatment

Anti-Bacterial Agents DRUG

Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.

Bioseal treatment; PRFG treatment

Nutrition support DIETARY_SUPPLEMENT

Nutritional replacement and bowel rest via enteral or parenteral nutrition.

Bioseal treatment; PRFG treatment

PRFG preparation PROCEDURE

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.

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)

Department of Surgery, Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Intestinal Fistula

Interventions

Anti-Bacterial Agents; 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; Therapeutics

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: August 19, 2012
• First Posted: August 27, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

CN (1)