Protocol summary

Summary
Limited sphincterotomy and endoscopic papillary balloon dilation (EPBD) is a low risk method in treatment of choleducolithiasis. But effective ballooning time is not clear. In this study, we compare five seconds and one minute ballooning time. This study is a unicentric, single blind, randomized clinical trial. This study is single-blind because participants will be deliberately kept ignorant of either the group to which they will be assigned, but the experimenter will be in possession of the ballooning time in each one. Sixteen to ninety years old patients eligible for treatment of choleducolithiasis, with no severe hepatic, biliary or systemic disease enroll in the study. Lack of consent to cooperate in trial, precut sphincterotomy or failure of cannulation of common hepatic duct will exclude the patient. After initial laboratory examinations, sixty patients randomly will be assigned to receive EPBD with either 5 seconds or one minute ballooning time after endoscopic retrograde cholangiopancreatography and small sphincterotomy. Maximum choledochal diameter, stone or stones count and largest stone diameter will be measured. Then stone or stones will be retrieved with balloon extractor. If stone or stones removed, the procedure is successful. Otherwise, it is unsuccessful. Serum amylase will be checked 2 hours after procedure. Patients will be fallowed 48 hours for abdominal pain, pancreatitis, perforation, hemorrhage and fever.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013033112877N1
Registration date: 2013-05-04, 1392/02/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-04, 1392/02/14
Registrant information
Name
Mohammad Hadi Shafigh Ardestani
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 5555
Email address
mhshafigh@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of one minute versus five seconds endoscopic biliary balloon dilation after small sphincterotomy in choleducolithiasis
Public title
Ballooning time after small sphincterotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 16 to 90 years old patients eligible for treatment of choleducolithiasis documented with ultrasonography or magnetic resonance cholangiopancreatography, no severe hepatic or systemic disease, no history of gastric or choledochal surgery (except cholecystectomy), no active pancreatitis, no previous sphincterotomy, no biliary stricture, no choledochal cyst, no addiction. Exclusion criteria: precut sphincterotomy, failure of cannulation of common hepatic duct, no stone in endoscopic retrograde cholangiopancreatography, lack of consent to cooperate in trial.
Age
From 16 years old to 90 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is single-blind because participants will be deliberately kept ignorant of either the group to which they will be assigned, but the experimenter will be in possession of the ballooning time in each one. Patients will be randomly assigned to one of the two groups by using a table of random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services
Street address
Building No.4, Isfahan University of Medical Sciences and Health Services, Hezarjarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2013-04-03, 1392/01/14
Ethics committee reference number
392004

Health conditions studied

1

Description of health condition studied
Choleducolithiasis
ICD-10 code
K80.5
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis

Primary outcomes

1

Description
Common Bile Duct stone clearance
Timepoint
Just after the intervention
Method of measurement
Observation (stone or stones extraction)

Secondary outcomes

1

Description
Abdominal pain
Timepoint
Every six hours up to 48 hours after the intervention
Method of measurement
History and physical examination

2

Description
Fever
Timepoint
Every six hours up to 48 hours after the intervention
Method of measurement
Oral thermometer, temperature equal or more than 38 degree of Celsius

3

Description
Serum amylase level
Timepoint
Before and 2 hours after the intervention
Method of measurement
ELISA kits: International Unit per Littre

4

Description
Hemorrhage
Timepoint
Every six hours up to 48 hours after the intervention
Method of measurement
History and physical examination

5

Description
Perforation
Timepoint
Every six hours up to 48 hours after the intervention
Method of measurement
History and physical examination

6

Description
Pancreatitis
Timepoint
Every six hours up to 24 hours after the intervention
Method of measurement
History, physical examination and serum amylase 2 hours after the procedure

Intervention groups

1

Description
After endoscopic retrograde cholangiopancreatography, minimal papillary sphincterotomy up to proximal fold will perform with sphincterotomy and electrocautery (blended current, 40-60 W). Then papillary balloon will be dilated with Trans The Scope Balloon (Cook medical Hercules® 3 Stage BalloonG31926, HBD-12-13.5-15) for five seconds. Then stone or stones will be retrieved with balloon extractor.
Category
Treatment - Surgery

2

Description
After endoscopic retrograde cholangiopancreatography, minimal papillary sphincterotomy up to proximal fold will perform with sphincterotomy and electrocautery (blended current, 40-60 W). Then papillary balloon will be dilated with Trans The Scope Balloon (Cook medical Hercules® 3 Stage BalloonG31926, HBD-12-13.5-15) for one minute. Then stone or stones will be retrieved with balloon extractor.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital, Endoscopy Department
Full name of responsible person
Mohammad Hadi Shafigh Ardestani
Street address
Al-Zahra Hospital, Soffeh Blvd., Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Peyman Adibi
Street address
Building No.4, Isfahan University of Medical Sciences and Health Services, Hezarjarib Street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Hadi Shafigh Ardestani
Position
Fellowship of Gastroenterology
Other areas of specialty/work
Street address
Gastroenterology Department, Al-Zahra Hospital, Soffeh Blvd., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
+98 31 1668 4510
Email
mhshafigh@resident.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Ahmad Shavakhi
Position
Associate Professor of Gastroenterology
Other areas of specialty/work
Street address
Gastroenterology Department, Al-Zahra Hospital, Soffeh Blvd., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
shavakhi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Hadi Shafigh Ardestani
Position
Fellowship of Gastroenterology
Other areas of specialty/work
Street address
Gastroenterology Department, Al-Zahra Hospital, Soffeh Blvd., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
mhshafigh@resident.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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