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Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Tracheobronchial Fistula

Primary Purpose

Tracheobronchial Fistula

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional treatment
PRP treatment
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheobronchial Fistula focused on measuring Tracheobronchial fistula, Platelet-rich plasma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with aged between 18 to 75
  • Subjects diagnosed with Tracheobronchial fistula(the sizes of the fistulas less than 2cm)
  • Subjects willing to accept PRP treatment
  • Subjects tolerant to the bronchoscope
  • Subjects signed informed consent

Exclusion Criteria:

  • Subjects with airway disease: congenital tracheobronchial fistula, recurrent polychondritis, etc;
  • Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc;
  • Subjects with malignant tumors or have a history of malignant tumors;
  • Subjects with uncontrolled systemic infection;
  • Subjects requiring anti-clotting drugs;
  • Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc;
  • Subjects with syphilis, HIV,HBV,HCV antibody positive;
  • Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc;
  • Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value;
  • Subjects with liver disease or liver damage: ALT,AST, total bilirubin > 2 times the upper limit of the normal value;
  • Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases;
  • Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction;
  • Subjects allergic to thrombin;
  • Subjects accepted by any other clinical study within the first three months of the study;
  • Subjects with poor compliance;
  • Any other conditions might increase the risk of the patient or interfere with the clinical study.

Sites / Locations

  • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

PRP group

Arm Description

Outcomes

Primary Outcome Measures

Cure rate for tracheobronchial fistula
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after three times of PRP treatment

Secondary Outcome Measures

clinical complete remission time
The interval time of the first intratracheal interventional therapy needed again after 3 times of PRP treatment
Times of unplanned treatment
The number of times a patient needs to be reviewed and treated by bronchoscopy for cough, expectoration and dyspnea
Incidence of complications associated with PRP treatment
fistula healing, sputum retention, etc. during follow-up

Full Information

First Posted
March 22, 2022
Last Updated
April 1, 2022
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT05304897
Brief Title
Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Tracheobronchial Fistula
Official Title
Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Tracheobronchial Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Platelet-rich plasma(PRP), is a concentrate of platelet-rich plasma protein derived from whole blood. The main components of it are platelets, leukocytes and fibrin. Autologous PRP treatment can avoid the immune rejection caused by exogenous growth factor and the spread of disease. Evidence of the efficacy and safety of PRP has been proven in many studies. Tracheobronchial fistula(TBF) refers to a pathological state in which there are abnormal passages between the trachea, bronchi and chest, esophagus, stomach, mediastinum, bile ducts and other organs or cavities. Bronchopleural fistulas and tracheobronchioesophageal fistulas are two common types og TBF, which are mainly manifested as choking on eating and repeated aspiration pneumonia. Respiratory intervention has become one of the most common treatments to fight the disease. Although the short-term occlusion effect of conventional treatment methods of respiratory intervention is relatively easy to achieve, there is great uncertainty in the long-term treatment effect, and long-term large fistulas have little chance of healing. PRP has shown significant efficacy for hyperplastic scar of skin. Correspondingly, PRP will be applied as treatment of TBF to cure fistula.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheobronchial Fistula
Keywords
Tracheobronchial fistula, Platelet-rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Title
PRP group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Conventional treatment
Intervention Description
Conventional treatments for Tracheobronchial fistula, including the application of metallic endoclips
Intervention Type
Procedure
Intervention Name(s)
PRP treatment
Intervention Description
PRP treatment following the conventional treatment for Tracheobronchial fistula
Primary Outcome Measure Information:
Title
Cure rate for tracheobronchial fistula
Description
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after three times of PRP treatment
Time Frame
within 6 months after administration
Secondary Outcome Measure Information:
Title
clinical complete remission time
Description
The interval time of the first intratracheal interventional therapy needed again after 3 times of PRP treatment
Time Frame
within 6 months after administration
Title
Times of unplanned treatment
Description
The number of times a patient needs to be reviewed and treated by bronchoscopy for cough, expectoration and dyspnea
Time Frame
within 6 months after administration
Title
Incidence of complications associated with PRP treatment
Description
fistula healing, sputum retention, etc. during follow-up
Time Frame
within 6 months after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with aged between 18 to 75 Subjects diagnosed with Tracheobronchial fistula(the sizes of the fistulas less than 2cm) Subjects willing to accept PRP treatment Subjects tolerant to the bronchoscope Subjects signed informed consent Exclusion Criteria: Subjects with airway disease: congenital tracheobronchial fistula, recurrent polychondritis, etc; Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc; Subjects with malignant tumors or have a history of malignant tumors; Subjects with uncontrolled systemic infection; Subjects requiring anti-clotting drugs; Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc; Subjects with syphilis, HIV,HBV,HCV antibody positive; Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc; Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value; Subjects with liver disease or liver damage: ALT,AST, total bilirubin > 2 times the upper limit of the normal value; Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases; Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction; Subjects allergic to thrombin; Subjects accepted by any other clinical study within the first three months of the study; Subjects with poor compliance; Any other conditions might increase the risk of the patient or interfere with the clinical study.
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD
Phone
8620-83062896
Email
lishiyue@188.com
First Name & Middle Initial & Last Name & Degree
Xiaobo Chen, MD
Phone
8620-83062896
Email
xiaobo-win@163.com
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Tracheobronchial Fistula

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