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Treatment Outcomes in Bile Duct Stones

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AdventHealth

Status

Completed

Conditions

Gallstone
Bile Duct Diseases
Bile Duct Obstruction

Treatments

Procedure: endoscopic retrograde cholangiopancreatography

Study type

Observational

Funder types

Other

Identifiers

NCT04145843
1504680

Details and patient eligibility

About

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

Full description

Gallstone diseases are common, affecting 20 million patients in the United States with associated costs of over US $6 billion. Common bile duct (CBD) stones in turn occur in 15-20% patients with gallstone disease and require treatment due to risk of infection and pancreatitis. Endoscopic treatment via endoscopic retrograde cholangiopancreatography (ERCP) is the treatment modality of choice in CBD stones. The most simple treatment techniques include biliary sphincterotomy and stone extraction via the use of standard devices such as a stone retrieval balloons or stone retrieval baskets. However, patients with difficult bile duct stones require advanced maneuvers namely mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided lithotripsy (SOC-LL).

Currently, there are no standardized treatment approaches in the management of CBD stones, especially in the management of difficult CBD stones. Therefore, ERCP in patients with difficult CBD stones can be inefficient and prolonged with use of multiple devices and techniques. In an effort to standardize the management of bile duct stones, we have devised an algorithm for the treatment of bile duct stones using current standard of care methods, taking into account the size of bile duct stones, size of bile duct and availability of endoscopic expertise. The objective of this registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. All patients with confirmed or suspected bile duct stones undergoing endoscopic therapy for treatment of bile duct stones
  2. Patients 18 years or over

Exclusion criteria

  1. Patients not undergoing endoscopic therapy for bile duct stones
  2. Patients < 18 years of age

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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