Comparing surgical treatment outcomes in patients with different lung diseases and breathing tube repair types
| ISRCTN | ISRCTN17157026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17157026 |
| Secondary identifying numbers | U1111-1269-2424 |
- Submission date
- 16/09/2021
- Registration date
- 20/09/2021
- Last edited
- 20/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
A pneumonectomy is a type of surgery to remove one of your lungs because of cancer, trauma, or some other condition.
After surgery there is a high risk of complications that may lead to death.
This trial aims to investigate which type of bronchi suture (the method used to close the end of the breathing tube in the removed lung) would better prevent complications after pneumonectomy in patients with different diseases.
Who can participate?
All patients who have had a pneumonectomy from 1959 to 2021 in six different Russian hospitals.
What does the study involve?
This is an observational study, which means that participants receive treatment as usual, depending on their condition. Patients receive primary drug treatment in accordance with the recommendations of the Russian Federation, and then they are offered surgery if their doctor think it is needed. Participants could receive medical treatment after surgery if needed.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
When is the study starting and how long is it expected to run for?
August 2021 to September 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Giller Dmitrii Borisovich, giller-thorax@mail.ru
Contact information
Scientific
19, Detskaya str.
Moscow
107258
Russian Federation
 ORCID ID |
0000-0003-1946-5193 |
|---|---|
| Phone | +7 9168681291 |
| giller-thorax@mail.ru |
Public
19, Detskaya str.
Moscow
107258
Russian Federation
| Phone | +7 9168681291 |
|---|---|
| giller-thorax@mail.ru |
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Broncho-Pleural Complications after Pneumonectomy depending on the disease and the bronchial suture type. Retrospective observational study. |
| Study acronym | BPCaP |
| Study objectives | 1. The manual no stump bronchial suture modified by D.B.Giller reduces the bronchopleural fistula risk in oncological, tuberculosis and nonspecific chronic inflammatory lung diseases patients 2. The original trachea-bronchial anastomosis and circular carina resection reduce the anastomosis failure risk. 3. The main bronchi suture modified by B.M.Giller reduces bronchopleural complications risk after pneumonectomy in patients with lung gangrene. |
| Ethics approval(s) | Approved 01/09/2021, I.M. Sechenov First Moscow State Medical University (Sechenov University) Local Ethics Committee (119991, Moscow, 8 Trubetskaya str., Russia; +7(495)622-97-06; iec@staff.sechenov.ru), ref: 15-21 |
| Health condition(s) or problem(s) studied | Pneumonectomy for pulmonary cancer, tuberculosis or nonspecific chronic inflammatory lung diseases. |
| Intervention | Patients who underwent pneumonectomy due to tuberculosis, oncology, or nonspecific chronic inflammatory disease are included in this trial. They have undergone treatment according to their disease and treatment standards of the period of hospitalization. Some patients, especially those with bilateral lesions, have undergone multi-stage surgical treatment. All patients signed a consent form before each intervention. Patients underwent the following tests: - Blood test - Mantoux test - Diaskin test - Spirometry - Blood gases test - CT scan - Fibrobronchoscopy - PET CT - MRI of the brain - Ultrasound of the organs of the ruddy cavity - Microbiological examination of sputum, surgical material with the additional use of accelerated diagnostic methods DR MBT (BACTEC, molecular genetic methods: real-time PCR - Xpert MTB / RIF biochips and PCR-TB; culture method); - Morphological, histological and cytological examination of biopsy material - Methods of statistical data processing. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured retrospectively using patient records: 1. Bronchopleural fistula development 2. 30-day postoperative mortality rate 3. Postoperative long term bronchopleural complications 4. Postoperative mortality due to bronchopleural complications |
| Secondary outcome measures | Measured retrospectively using patient records: 1. Surgery efficacy in patients with tuberculosis measured using 1.1. Sputum culture conversion rate after surgery and one, three and five years after surgery 1.2. Presence of cavities in pulmonary tissue (CV+/CV-) determined with CT scan/digital X-ray on discharge from the hospital, one, three and five years post-surgery. 2. Surgery efficacy in oncology patients measured using 2.1. Clear resections edges 2.2. R0 resection 2.3. 5-year survival rate 3. Surgery efficacy in patients with nonspecific chronical inflammatory lung diseases measured using absence of inflammatory process according to microbiological, roentgenological and clinical analysis after surgery and one, three and five years after surgery. 4. Five-year survival rate |
| Overall study start date | 30/08/2021 |
| Completion date | 01/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 2001 |
| Total final enrolment | 2001 |
| Key inclusion criteria | All patients who have had a pneumonectomy from 1959 to 2021 at the following institutions: 1. State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Anti-Tuberculosis Dispensary" 38, Vorovskogo str., Chelyabinsk, Russian Federation, 454092. From 1959 to 2004 2. Central TB Research Institute, 2, Yauzskaya alley, Moscow, Russian Federation, 107564 From 2004-2011 3. Sechenov University Phthisiopulmonology Clinical Hospital, 4, Dostoevskogo str., Moscow, Russian Federation, 127473. From 2011 to 2017 4. Ingush Republican TB Dispensary, 1, Bolnichnaya str., Plievo Village, Nazranovsky District, Republic of Ingushetia, Russian Federation, 386124. From 2018 to 2021 5. Regional Clinical Tuberculosis Dispensary, 22, Volskaya str., Saratov, Russian Federation, 410056. From 2018 to 2021 6. JSC «MEDICINE» (CLINIC OF ACADEMICIAN ROYTBERG), 10, 2nd Tverskoy-Yamskoy Pereulok, Moscow, Russian Federation, 125047. From 2018 to 2021 |
| Key exclusion criteria | 1. Patients admitted before 14/11/1959 and after 01/09/2021 2. Patients who passed lung resections in volume less than pneumonectomy |
| Date of first enrolment | 14/11/1959 |
| Date of final enrolment | 01/09/2021 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Chelyabinsk
454092
Russian Federation
Moscov
107564
Russian Federation
Moscow
127473
Russian Federation
Plievo Village
386124
Russian Federation
Saratov
410056
Russian Federation
Moscow
125047
Russian Federation
Sponsor information
University/education
8-2 Trubetskaya str.
Moscow
119991
Russian Federation
| Phone | +7 (495) 622-95-86 |
|---|---|
| id@1msmu.ru | |
| Website | https://sechenov.ru/eng/ |
"ROR" |
https://ror.org/02yqqv993 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 26/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
20/09/2021: Trial's existence confirmed by I.M. Sechenov First Moscow State Medical University (Sechenov University) Local Ethics Committee.
