Surgical treatment outcomes in patients passed VATS thoracoplasty for pulmonary tuberculosis

ISRCTN ISRCTN67743278
DOI https://doi.org/10.1186/ISRCTN67743278
Secondary identifying numbers U1111-1237-3349
Submission date
01/08/2019
Registration date
05/08/2019
Last edited
23/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Dmitry Giller
Scientific

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

ORCiD logoORCID ID 0000-0003-1946-5193
Phone +79168681291
Email giller-thorax@mail.ru

Study information

Study designObservational retrospective study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleVATS Treating Thoracoplasty in Destructive Pulmonary Tuberculosis Treatment
Study acronymThorTB
Study objectivesVATS 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(s)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
Health condition(s) or problem(s) studiedPulmonary tuberculosis
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measure1. 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 measures1. 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 study start date01/01/1999
Completion date23/12/2017

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participants208
Total final enrolment208
Key inclusion criteria1. Diagnosis of pulmonary tuberculosis.
2. Admitted to our clinic between 1999 and 2017.
3. Indications for thoracoplasty.
Key exclusion criteriaN/A
Date of first enrolment01/09/2017
Date of final enrolment23/12/2017

Locations

Countries of recruitment

  • Russian Federation

Study participating centre

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

Sponsor information

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

8 Trubetskaya str.
Moscow
119048
Russian Federation

Phone +7 (495) 622-95-86
Email id@1msmu.ru
Website https://www.sechenov.ru/eng/
ROR logo "ROR" https://ror.org/02yqqv993

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/02/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planA 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 planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2020 23/11/2020 Yes No

Editorial Notes

23/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
05/08/2019: Trial's existence confirmed by the I.M. Sechenov First Moscow State Medical University local ethics committee.