The Cost Effectiveness of Endoscopic Ultrasound ( EUS ) Based Strategy in Diagnosis of Common Bile Duct Stones

NCT02349568 | Completed DMC

• 1 other identifier: EC-55-066-21-1-2
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple reports in the literature showed the efficacy of EUS comparable to ERCP in the diagnosis of common bile duct ( CBD ) stone. The EUS-based strategy has provided the cost effectiveness in diagnosis of CBD stone in defined patient risk groups was showed in previous studies. The aim of our study was to assess the cost effectiveness of EUS based strategy versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risks for CBD stones in a real working situation in a developing country.

Conditions

Common Bile Duct Calculi

Outcome Measures

Primary Outcomes (1)

• The cost of making diagnosis of CBD stone

  The cost of making diagnosis of CBD stone will be measured as the difference in the cost of all patients undergoing ERCP and ERCP follow by EUS intervention. The cost was evaluated by (1) mean costs of EUS and ERCP based on the actual cost in our center which included costs of medical staffs, disposable materials, drugs, equipment amortization and maintenance. (2) costs associated with complications induced by the procedure.

  within 12 months after EUS

Secondary Outcomes (2)

• The accuracy of EUS in diagnosis of CBD stone

  within 12 months after EUS

• The safety of EUS and ERCP procedure

  within 1 months

Study Arms (2)

High risk group

High risk group was defined when CBD stones was detected by ultrasound ( US ) / computed tomography ( CT ) or dilated duct with abnormal LFT.

Procedure: High risk group

Intermediate risk group

Intermediate risk group was defined when US/CT showed normal bile duct with abnormal LFT or dilated duct with normal LFT.

Procedure: Intermediate risk group

Interventions

High risk group PROCEDURE

Patients with high risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. All patients even if negative EUS examination of CBD stone were underwent ERCP in the same session. The ERCPs were performed in standard manner. All patients were contacted by phone on day 1, 3 and 30 after the procedure.

Also known as: EUS examination follow by ERCP

High risk group

Intermediate risk group PROCEDURE

Patients with intermediate risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. ERCPs were done at the discretion of the attending physicians. The ERCPs were performed in standard manner. The patients without ERCP done were contacted at 3 months interval to assess symptoms and LFT for 12 months.

Also known as: EUS examination follow by ERCP or clinical follow up

Intermediate risk group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with suspected CBD stones based on clinical, biochemical and imaging by trans-abdominal ultrasonography or computed tomography..

You may qualify if:

• history of biliary pain or recent cholangitis
• acute pancreatitis
• abnormal liver function test
• dilatation of CBD and or CBD stone detected by trans-abdominal ultrasound and or computed tomography.

You may not qualify if:

• unstable hemodynamics
• severe coagulopathy
• refusal to participate

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bancha Ovartlarnporn, MD

  NKC Institue of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkla, Thailand.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NKC Institute of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 29, 2015
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

TH (1)