Status:

UNKNOWN

Endoclip Papillaplasty Restores Sphincter of Oddi Function

Lead Sponsor:

Peking University Third Hospital

Conditions:

Sphincter of Oddi Function

Eligibility:

All Genders

18-85 years

Brief Summary

Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones...

Detailed Description

Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones...

Eligibility Criteria

Inclusion

  • \- 1)18-85 years of age; 2) informed consent obtained before ERCP; 3) CBD diameter ≥12 mm; 4) CBD gallstones visualized at magnetic resonance cholangiopancreatography (MRCP) with at least one gallstone ≥10 mm (transverse diameter)

Exclusion

  • gallstone transverse diameter \>35 mm, which is not appropriate to be extracted;
  • history of previous sphincterotomy, previous EPBD;
  • accompanied with choledochoduodenal fistula, coagulopathy, anticoagulant/antiplatelet therapy, or Billroth II or Roux-en-Y reconstruction;
  • papilla located deep within a diverticulum;
  • small papilla and short intramural segment, which was not suitable for large EST;
  • medications known to affect the SO (calcium channel blockers, nitrates, opiates, and anticholinergics) taken within 48 h of the procedure;
  • benign or malignant biliary stricture.

Key Trial Info

Start Date :

May 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2021

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03795584

Start Date

May 1 2018

End Date

May 1 2021

Last Update

August 5 2020

Active Locations (1)

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Peking University Third Hosptial

Beijing, Beijing Municipality, China, 100000