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Ballooning time after small sphincterotomy

A comparative study of one minute versus five seconds endoscopic biliary balloon dilation after small sphincterotomy in choleducolithiasis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013033112877N1
Enrollment
60
Registered
2013-05-04
Start date
2013-04-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choleducolithiasis. Calculus of bile duct without cholangitis or cholecystitis

Interventions

Intervention 1: After endoscopic retrograde cholangiopancreatography, minimal papillary sphincterotomy up to proximal fold will perform with sphincterotomy and electrocautery (blended current, 40-60 W
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 papilla
After endoscopic retrograde cholangiopancreatography, minimal papillary sphincterotomy up to proximal fold will perform with sphincterotomy and electrocautery (blended current, 40-60 W). Then papillar

Sponsors

Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 90 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Common Bile Duct stone clearance. Timepoint: Just after the intervention. Method of measurement: Observation (stone or stones extraction).

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hadi Shafigh Ardestani

Isfahan University of Medical Sciences and Health Services

mhshafigh@resident.mui.ac.ir+98 31 1668 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026