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Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

Primary Purpose

Airway Disease, Fistula Bronchial, Fistula, Gastric

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Airway stent implantation

About this trial

This is an interventional treatment trial for Airway Disease focused on measuring 3D printed, airway stent, carina, distal bronchi

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT.
The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment.

Exclusion Criteria:

Severe infection
coagulation disorders

Sites / Locations

Shanghai Tongren HospitalRecruiting
Ruijin Hospital Luwan BranchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Segmented Airway Stent for Gastro-Respiratory fistula

Arm Description

Segmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula.

Outcomes

Primary Outcome Measures

Relief of symptoms

Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.

Heal of fistula

The heal of fistula confirmed by gastroscopy, bronchoscopy and CT

Secondary Outcome Measures

Number of participants with adverse events that are related to stent implantation

Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion

Stent patency time

Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive

Full Information

NCT ID

NCT03890523

First Posted

March 19, 2019

Last Updated

February 7, 2020

Sponsor

Ruijin Hospital

Collaborators

Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital, Ruijin Hospital Luwan Branch

1. Study Identification

Unique Protocol Identification Number

NCT03890523

Brief Title

Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

Official Title

Covered Metallic Segmented Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

November 1, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital, Ruijin Hospital Luwan Branch

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this study, the investigators used the covered metallic segmented airway stent modified with 3D printing to treat gastro-respiratory fistula involving carina and distal bronchi and aimed to determine the feasibility, efficacy and safety of this technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Airway Disease, Fistula Bronchial, Fistula, Gastric

Keywords

3D printed, airway stent, carina, distal bronchi

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Segmented Airway Stent for Gastro-Respiratory fistula

Arm Type

Experimental

Arm Description

Segmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula.

Intervention Type

Procedure

Intervention Name(s)

Airway stent implantation

Other Intervention Name(s)

Stent removal

Intervention Description

The segmented airway stent modified with 3D printing were implanted to treat gastro-respiratory fistula involving carina and distal bronchi. The stents were removed because of stent-related complications or tracheobronchial healing.

Primary Outcome Measure Information:

Title

Relief of symptoms

Description

Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.

Time Frame

1 month

Title

Heal of fistula

Description

The heal of fistula confirmed by gastroscopy, bronchoscopy and CT

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Number of participants with adverse events that are related to stent implantation

Description

Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion

Time Frame

6 months

Title

Stent patency time

Description

Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT. The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment. Exclusion Criteria: Severe infection coagulation disorders

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhongmin Wang, MD

Phone

0086-13901848333

wzm0722@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qungang Shan, MD

Phone

0086-15989037568

qungangshan@sjtu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhongmin Wang, MD

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Tongren Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aiwu Mao, MD

Facility Name

Ruijin Hospital Luwan Branch

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ju Gong

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

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