Skip to content

Comparison of 60-seconds versus 30-seconds endoscopic balloon dilation after endoscopic sphincterotomy for the management of bile duct stones

A randomized comparison of 60-seconds versus 30-seconds endoscopic balloon dilation after endoscopic sphincterotomy for the management of bile duct stones

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13081712
Enrollment
124
Registered
2012-07-09
Start date
2009-09-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Bile duct stones Digestive System Cholelithiasis

Interventions

Full length endoscopic sphincterotomy (ES) followed by 60-seconds versus 30-seconds balloon dilation (BD) for cases with large unretrieved stones, multiple stones and tapering or tortuosity of distal

Sponsors

Venizelio Hospital (Greece)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with bile duct stones= 12mm (transverse diameter of the largest stone) that could not be extracted using a standard balloon catheter in the common bile duct

Exclusion criteria

Exclusion criteria: 1. Need for needle knife pre-cutting 2. Selective bile duct cannulation achieved after more than two accidental pancretograms or more than two insertions of the guidewire in the pancreatic duct 3. Cases with bleeding tendency (taking anticoagulant therapy, platelet count of less than 100.000/mm3, or prothrombin time more than 30% above the control 4. Billroth II or Roux-en ?Y reconstruction 5. Bile duct stones with diameter =20mm 6. Strictures 7. Patients undergoing anticoagulant or antiplatelet therapy for non-critical problems, such as cardiovascular and cerebral disorders, were instructed to discontinue the use of these types of medication at least 7 days before the endoscopic procedure

Design outcomes

Primary

MeasureTime frame
Our data showed that 30-sec BD after ES for the management of bile duct stones was equally effective as 60-sec. Therefore, there is no need to exceed 30 seconds when removing stones from bile ducts with balloon dilation.

Secondary

MeasureTime frame
Study showed that the rate of post-procedure complications was not different between the two groups

Countries

Greece

Outcome results

None listed

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