Condition category
Respiratory
Date applied
01/08/2019
Date assigned
05/08/2019
Last edited
05/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tuberculosis (TB) is a bacterial infection that commonly affects the lungs. There are antibiotics that can treat TB, but some strains of the bacteria are resistant to one or more of these antibiotics and the infection can become hard to treat using medicines. It is also possible to treat drug-resistant TB with surgery, by removing infected parts of the lung or collapsing the lung to close cavities. The aim of this study is to follow-up patients with TB who passed surgery for lung cavities collapsing to investigate how surgical treatment affects their TB infection status.

Who can participate?
All patients at a Moscow Hospital with spread TB who had no indications for lung resection between 1999 and 2017.

What does the study involve?
This is an observational study, which means that participants received treatment as usual depending on their condition. Patients received initial drug treatment according to Russian Federation guidelines and then were offered surgery if their doctor thought it was appropriate. Participants could receive drug treatment after surgery as appropriate.

What are the possible benefits and risks of participating?
There were no additional risk for participants enrolled in the study, because their treatment was performed according to guidelines. Participants could benefit from free examinations and additional follow-up and treatment.

Where is the study run from?
I.M. Sechenov First Moscow State Medical University (Russian Federation)

When is the study starting and how long is it expected to run for?
January 1999 to December 2017

Who is funding the study?
The investigator is funding the study.

Who is the main contact?
Professor Dmitry Giller, giller-thorax@mail.ru

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dmitry Giller

ORCID ID

http://orcid.org/0000-0003-1946-5193

Contact details

I.M. Sechenov First Moscow State Medical University (Sechenov University)
8 Trubetskaya str.
Moscow
119048
Russian Federation
+79168681291
giller-thorax@mail.ru

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

U1111-1237-3349

Study information

Scientific title

VATS Treating Thoracoplasty in Destructive Pulmonary Tuberculosis Treatment

Acronym

ThorTB

Study hypothesis

VATS thoracoplasty application has the same efficacy rate as a standard one but without the typical side effects (chest deformation, muscle atrophy, shoulder girdle dysfunction, etc.).

Ethics approval

Approved 17/07/2019, I.M. Sechenov First Moscow State Medical University (Sechenov University) Local Ethics Committee 119991 (8 Trubetskaya str. Building 1, Moscow, Russia; +7 495 622-97-06), ref: 10-19

Study design

Observational retrospective study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Pulmonary tuberculosis

Intervention

Patients with determined destructive pulmonary tuberculosis resistance were enrolled in study.

Before surgery was considered, they were treated with antitubercular chemotherapy using one of the standard chemotherapy regimens in the Russian Federation (Guidelines for improving the diagnosis and treatment of respiratory tuberculosis (approved by order of the Ministry of Health of the Russian Federation dated December 29, 2014 No. 951) depending on the degree of drug resistance and patient examination.

Indications for thoracoplasty were single/multiple cavity(ies) in the upper-posterior segments of the upper lobe and/or S6 of the one/both lungs combined with massive seeding that does not allow for a lung resection to be performed. In addition, we often perform this technique to correct the hemithorax volume after lung resections for prevention of pulmonary tissue hyperextension and TB reactivation. Other important data in favor of surgical treatment are MDR or XDR mycobacteria, absence of positive dynamics despite adequate regimen, and timing of chemotherapy and pulmonary hemorrhage.

The surgery technique involves an incision of 4–8 cm on the decostation side along the paravertebral line in the projection of the II–IV rib necks. Together with the scapula, the dissected muscles are retracted from the external surface of the ribs, that creates cavity above decostation plane. With thoracoscopy application, we perform upper ribs resection to create collapse on affected pulmonary parenchyma.

Between 1999 and 2017, we performed 925 VATS thoracoplasties. In 208 patients it was employed as a treating procedure. All patients signed consent before every intervention. Follow-up was performed regularly for up to 5 years, with observation duration of 6 years.


All groups received treatment in the same hospital and received the following tests:
1. Blood test
2. Mantoux test
3. Diaskin test
4. Spirometry
5. Blood gases
6. CT scan
7. Fibrobronchoscopy;
8. Microbiological examination of sputum, an operational material with the additional use of accelerated diagnostic methods of DR MBT (BACTEC, molecular genetic methods: real-time PCR - Xpert MTB / RIF and PCR-TB biochips; cultural method);
9. Morphological study of gross section
10. Methods of statistical data processing.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Presence of cavities in pulmonary tissue (CV+/CV-) determined with CT scan/digital X-ray on discharge from the hospital.
2. Presence of M tuberculosis assessed using AFB smear test of sputum (AFB+/AFB-) using sputum fluorescent microscopy and culture method on discharge from the hospital.

Secondary outcome measures

1. Presence of cavities in pulmonary tissue (CV+/CV-) determined with CT scan/digital X-ray every year for 5 years (1st, 2nd, 3rd, 4th, 5th year) after discharge.
2. Presence of M tuberculosis assessed using AFB smear test of sputum (AFB+/AFB-) using sputum fluorescent microscopy and culture method every year for 5 years (1st, 2nd, 3rd, 4th, 5th year) after discharge.
3. TB relapse assessed by clinical follow-up for up to 5 years (1st, 2nd, 3rd, 4th, 5th year) after discharge.

Overall trial start date

01/01/1999

Overall trial end date

23/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of pulmonary tuberculosis.
2. Admitted to our clinic between 1999 and 2017.
3. Indications for thoracoplasty.

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

208

Participant exclusion criteria

N/A

Recruitment start date

01/09/2017

Recruitment end date

23/12/2017

Locations

Countries of recruitment

Russian Federation

Trial participating centre

I.M. Sechenov First Moscow State Medical University (Sechenov University)
8 Trubetskaya str.
Moscow
119048
Russian Federation

Sponsor information

Organisation

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Sponsor details

8 Trubetskaya str.
Moscow
119048
Russian Federation
+7 (495) 622-95-86
id@1msmu.ru

Sponsor type

University/education

Website

https://www.sechenov.ru/eng/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A publication titled " VATS Treating Thoracoplasty in Destructive Pulmonary Tuberculosis Treatment " is planned to be submitted to a journal by 01/08/2019.

2018 results presented at the 26th European Conference on General Thoracic Surgery in http://www.ests2018.com/static/upload/ow76/events/ev195/Site/files/ESTS18_Publication_BoA_v3-2205.pdf Book of Abstracts (see abstract P-74, page 289)

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/02/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/08/2019: Trial's existence confirmed by the I.M. Sechenov First Moscow State Medical University local ethics committee.