Comparing surgical treatment outcomes in patients with different levels of drug-resistant tuberculosis

ISRCTN	ISRCTN71922508
DOI	https://doi.org/10.1186/ISRCTN71922508
Secondary identifying numbers	U1111-1236-2168

Submission date: 01/07/2019
Registration date: 02/07/2019
Last edited: 02/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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, whether they were treated with surgery or not, so investigate how surgical treatment affects their TB infection status, level of disability and survival.

Who can participate?
All patients at a Moscow Hospital who were diagnosed with drug-resistant TB between 2011 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?
October 2011 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 ID	0000-0003-1946-5193
Phone	+79168681291
Email	giller-thorax@mail.ru

Study information

Study design	Observational retrospective study
Primary study design	Observational
Secondary study design
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Pulmonary tuberculosis surgical treatment in patients with multiple and extensive drug-resistant mycobacterial infection
Study acronym	PTS MEDR
Study objectives	Radical and semi-radical surgical treatment application can increase treatment efficacy of patients with destructive pulmonary tuberculosis with multiple and extensive drug-resistant Mycobacterium tuberculosis infection.
Ethics approval(s)	Approved 06/03/2013, 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: 03-13
Health condition(s) or problem(s) studied	Pulmonary tuberculosis
Intervention	Patients with determined drug resistance were enrolled in study and divided into five groups depending on drug resistance: extensively drug-resistant (XDR), multiple drug-restistant (MDR), poly-drug-resistant (PolyDR), monodrug-resistant (MonoDR) and drug-sensitive (DS). 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) https://www.garant.ru/products/ipo/prime/doc/70749840/) depending on the degree of drug resistance and patient examination. Before surgery patients had on average 3-6 months of chemotherapy. Then surgery was performed. Some patients, especially with bilateral lesions had multistage surgical treatment. Overall 2172 surgeries was performed in 1259 patients. Surgeries performed were: thoracoplasty, segmentectomy, combined polysegmental resections, lobectomy, bilobectomy, lobectomy plus segmentectomy, pneumonectomy, pleuropneumonectomy, transsternal main bronchus occlusion. All patients signed consent before every intervention. Follow-up was performed regularly up to 5 years, with observation duration of 6 years. For a more objective assessment of the study results , each of the above groups were divided into three subgroups, depending on the radical surgery degree: - Radical (no TB alterations in pulmonary parenchyma and intrathoracic lymphadenopathy [ITLN] verified with computerise tomography [CT]) - Semi-radical (remaining foci or tuberculomas without destruction in operated/contralateral lung; cases with remained cavern under thoracoplasty were also included, because tendency for cavity closureis usually observed in terms up to 6 months.) - Palliative (cases with bilateral cavitary TB, when surgery was applied just on one side due to patient’s rejection of treatment or low cardiorespiratory reserves; elimination of life-threatening conditions without destructions removal) All groups received treatment in the same hospital and received the following tests: - Blood test - Mantoux test - Diaskin test - Spirometry - Blood gases - CT scan - Fibrobronchoscopy; - 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); - Morphological study of gross section - Methods of statistical data processing.
Intervention type	Procedure/Surgery
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 up to 5 years (1st, 2nd, 3rd, 4th, 5th year) after discharge. 4. Degree of disability assessed by checking patients' documentation and anamnesis (patentient's account of medical history) during follow-up up to 5 years (1st, 2nd, 3rd, 4th, 5th year) after discharge. 5. Survival assessed by follow-up up to 5 years (1st, 2nd, 3rd, 4th, 5th year) after discharge.
Overall study start date	16/10/2011
Completion date	23/12/2017

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	1259
Key inclusion criteria	Every patient with a diagnosis of drug-resistant M tuberculosis admitted in our clinic between 2011 and 2017 was included in this study.
Key exclusion criteria	Patients with unknown drug resistance admitted in our clinic between 2011 and 2017
Date of first enrolment	16/10/2011
Date of final enrolment	23/12/2017

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"	https://ror.org/02yqqv993

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/02/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	A publication titled "Long Term Surgical Treatment Results Of Multi And Extensive Drug Resistant Pulmonary Tuberculosis, Depending On Radical Surgery Degree" is planned to be submitted to a journal by 01/08/2019. 2019 results presented at the 27th European Conference on General Thoracic Surgery in https://emma.events/static/upload/ow76/events/ev222/Site/files/ESTS19_Publication_BoA_FINALVERSION.pdf (see abstract O-021)
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Editorial Notes

01/07/2019: Trial's existence confirmed by Sechenov University Ethics Committee.