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IRCT2013033112877N1 IRCT 2013-05-04 Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services Ballooning time after small sphincterotomy A comparative study of one minute versus five seconds endoscopic biliary balloon dilation after small sphincterotomy in choleducolithiasis 2013-04-04 anticipated 60 Complete https://irct.ir/trial/12889 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 1-2 Choleducolithiasis. Intervention 1: 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. Intervention 2: 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.
public Mohammad Hadi Shafigh Ardestani
Gastroenterology Department, Al-Zahra Hospital, Soffeh Blvd., Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1668 5555 mhshafigh@resident.mui.ac.ir Isfahan University of Medical Sciences and Health Services scientific Ahmad Shavakhi
Gastroenterology Department, Al-Zahra Hospital, Soffeh Blvd., Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1668 5555 shavakhi@med.mui.ac.ir Isfahan University of Medical Sciences and Health Services Iran (Islamic Republic of) 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. 16 years 90 years Both K80.5 Calculus of bile duct without cholangitis or cholecystitis Treatment - Surgery Treatment - Surgery 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. 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. Common Bile Duct stone clearance. Timepoint: Just after the intervention. Method of measurement: Observation (stone or stones extraction). Abdominal pain. Timepoint: Every six hours up to 48 hours after the intervention. Method of measurement: History and physical examination. 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. Serum amylase level. Timepoint: Before and 2 hours after the intervention. Method of measurement: ELISA kits: International Unit per Littre. Hemorrhage. Timepoint: Every six hours up to 48 hours after the intervention. Method of measurement: History and physical examination. Perforation. Timepoint: Every six hours up to 48 hours after the intervention. Method of measurement: History and physical examination. 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. Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services Approved 2013-04-03 Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services Building No.4, Isfahan University of Medical Sciences and Health Services, Hezarjarib Street, Isfahan Isfahan Iran (Islamic Republic of)