Comparison of endoscopic papillary large balloon dilation with balloon sizes more and less than 15 mm with limited sphincterotomy in management of large common bile duct stones in Taleghani hospital 2017-2018
Comparison of clinical outcomes and complications of endoscopic dilatation balloons between balloons with size more and less than 15 mm
Design
This study is a randomized, single-blind, randomized clinical trial. The first group consists of patients with a balloon dilatation size of more than 15 mm and the second group consists of patients whose balloon size is less than 15 mm.
Settings and conduct
All patients admitted to the gastrointestinal ward of Ayatollah Taleghani Hospital in Tehran who have bile ducts above 15 mm and who are candidates for balloon dilatation with a large balloon will be included in the study. Clinical outcomes and endoscopic effects of balloon dilatation will be compared between balloons above 15 and below 15 mm. Demographic data, clinical data, clinical outcomes of balloon dilatation and complications of the procedure are recorded and compared between the two groups.
Participants/Inclusion and exclusion criteria
Patients with large biliary stones larger than 15 mm in diameter under the balloon dilatation at Tehran Taleghani Hospital enrolled in the study.
exclusion criteria include patient dissatisfaction, patients with a history of sphincterotomy, coagulation disorder, renal failure, cirrhosis, bile duct stenosis, biliary dystrophy.
Intervention groups
30 patients were randomly assigned into two groups (the first group was balloon dilatation with a balloon greater than 15 mm and the second group with a balloon less than 15 mm)
Main outcome variables
Demographic data; Clinical information; Clinical outcomes of the balloon dilation; complications from the procedure; bleeding; probable mortality of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181117041684N1
Registration date:2019-08-13, 1398/05/22
Registration timing:registered_while_recruiting
Last update:2019-08-13, 1398/05/22
Update count:0
Registration date
2019-08-13, 1398/05/22
Registrant information
Name
parna sadat Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 9614
Email address
parna.hosseini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of endoscopic papillary large balloon dilation with balloon sizes more and less than 15 mm with limited sphincterotomy in management of large common bile duct stones in Taleghani hospital 2017-2018
Public title
Comparison of endoscopic papillary large balloon dilation in management of large common bile duct stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with large biliary stones (with a stone size greater than 15 mm)
Exclusion criteria:
History of sphincterotomy, coagulation disorder, renal failure, cirrhosis, distal stenosis of the biliary duct, biliary diverticulum
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are not aware that they are less than or equal to 15 mm in the balloon group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Taleghani hospital, Araabi st, Yaman Ave, Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
145678908
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.SBMU.MSP.REC.1398.294
Health conditions studied
1
Description of health condition studied
Bile duct stone
ICD-10 code
K83.9
ICD-10 code description
Disease of biliary tract, unspecified
Primary outcomes
1
Description
The success rate of bilary stone excretion and post-endoscopic complications.
Timepoint
onest of balloon dilation until a day after procedure
Method of measurement
observation of excerted stone and Examination of post-endoscopic complication
Secondary outcomes
empty
Intervention groups
1
Description
A group of patients treated with a balloon less than 15 mm in size.
Category
Treatment - Devices
2
Description
A group of patients treated with a balloon more than 15 mm in size.