Suspended

Glue-sealingA Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs

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What is being tested

Endoscopy exploration and glue application

+ Anti-Bacterial Agents

+ Nutrition support

ProcedureDrugDietary Supplement
Who is being recruted

Digestive System Diseases+5

+ Fistula

+ Gastrointestinal Diseases

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorJinling Hospital, China
Study ContactJianan Ren, MDMore contacts
Last updated: March 11, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01672593
Principal SponsorJinling Hospital, China
Study ContactJianan Ren, MDMore contacts
Last updated: March 11, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFistulaGastrointestinal DiseasesIntestinal DiseasesPathological Conditions, Signs and SymptomsDigestive System FistulaPathological Conditions, AnatomicalIntestinal Fistula

Criteria

4 inclusion criteria required to participate
Low output volume ( < 200 ml/24h)
Patients with a single tubular ECF
Tract diameter < 1cm
Tract length > 2cm
5 exclusion criteria prevent from participating
Abscess
Cancer-infiltrated fistula
Distal bowel obstruction
Foreign bodies
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Surgery, Jinling Hospital

Nanjing, ChinaOpen Department of Surgery, Jinling Hospital in Google Maps
SuspendedOne Study Center