Subcutaneous octreotide therapy for malignant pleural effusion after pleurodesis with talc powder: A placebo-controlled, triple-blind, randomized trial
In this study, we intended to investigate the therapeutic effects and safety of octreotide in patients with MPE undergoing pleurodesis with talc powder.
Design
A placebo-controlled, triple-blind, randomized trial
Settings and conduct
It was performed at the thoracic surgery ward of Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran from March 2020 to March 2021
Participants/Inclusion and exclusion criteria
Included participants were patients with confirmed cancer and MPE that were candidates for pleurodesis with talc using pleuroscopy due to the need for repeated pleural drainage. MPE was diagnosed based on thoracocentesis and cytological examination of pleural fluid. Other inclusion criteria were 1) age>18 years old, 2) chest tube discharge>150 cc/day, and 3) estimated survival>6 months. Exclusion criteria were 1) lung entrapment, 2) concomitant chemotherapy or radiotherapy, 3) treatment with Warfarin, 4) uncontrolled diabetes mellitus, 5) cholestasis, 6) pregnancy, and 7) sensitivity to octreotide.
Intervention groups
َA pleural catheter was implanted for all patients. Patients in the octreotide group received 50-microgram subcutaneous injections of octreotide acetate (Novartis, Switzerland) three times/day for up to 5 days prior to the pleurodesis. When the chest tube discharge declined to less than 150 cc per day, the patient underwent pleurodesis with talc using pleuroscopy.
Main outcome variables
The primary outcome measures of this study were the amount of discharge from the chest tube before and after pleurodesis and the length of hospital stay.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210915052492N1
Registration date:2021-10-11, 1400/07/19
Registration timing:retrospective
Last update:2021-10-11, 1400/07/19
Update count:0
Registration date
2021-10-11, 1400/07/19
Registrant information
Name
Matin Vahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 4676
Email address
h-sanjarimoghaddam@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-01, 1398/12/11
Expected recruitment end date
2021-03-01, 1399/12/11
Actual recruitment start date
2020-03-01, 1398/12/11
Actual recruitment end date
2021-03-01, 1399/12/11
Trial completion date
2021-03-01, 1399/12/11
Scientific title
Subcutaneous octreotide therapy for malignant pleural effusion after pleurodesis with talc powder: A placebo-controlled, triple-blind, randomized trial
Public title
Subcutaneous octreotide therapy for malignant pleural effusion after pleurodesis with talc powder: A placebo-controlled, triple-blind, randomized trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cancer and malignant pleural effusion
Chest tube discharge>150 cc/day
Estimated survival>6 months
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
46
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomized and allocated into two equal groups with a ratio of 1:1 and a block size of 4. A specific random code was created using Microsoft Office Excel and given to each patient.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Allocated drugs were presented by these codes, so their relationships were kept confidential and were not revealed until the end of the study. Distinct individuals performed randomization, assessment, drug administration, and data entry. Octreotide and placebo ampules were indistinguishable regarding their shape and color. The patients, researchers, and statisticians were blinded to drug allocations.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Tehran University of Medical Sciences
Street address
Tehran university of medical sciences, Poursina St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419783151
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.TUMS.IKCH.REC.1399.498
Health conditions studied
1
Description of health condition studied
Malignant pleural effusion
ICD-10 code
J91.0
ICD-10 code description
Malignant pleural effusion
Primary outcomes
1
Description
The amount of discharge from the chest tube before and after pleurodesis
Timepoint
Before and after intervention
Method of measurement
Chest tube
Secondary outcomes
1
Description
Hospital stay
Timepoint
After intervention
Method of measurement
Days
Intervention groups
1
Description
Intervention group: Patients in the octreotide group received 50-microgram subcutaneous injections of octreotide acetate (Novartis, Switzerland) three times/day for up to 5 days prior to the pleurodesis. When the chest tube discharge declined to less than 150 cc per day, the patient underwent pleurodesis with talc using pleuroscopy.
Category
Treatment - Drugs
2
Description
Control group: Patients in the placebo group underwent the exact treatment and surgery protocols but received subcutaneous injections of NaCl 0.9% instead of octreotide.