The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03504293
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Actual Duration (Months): 131.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.

The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; Biliary Stricture; Biliary Tract Neoplasms; Biliary Tract Diseases	Procedure: Combinatory EUS and ERCP

Detailed Description

The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.

The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sahlgrenska EUS ERCP Study
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Dec 15, 2020

Outcome Measures

Primary Outcome Measures

1. Diagnostic accuracy [12 months post-EUS]

   Overall accuracy of ERCP and EUS

Secondary Outcome Measures

1. Adverse event rate [30 days post-EUS]

   The number of patients ending up with some type of complication related to ERCP or EUS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up

Exclusion Criteria:

• Patients unwilling to participate

• Patients unfit for EUS and ERCP

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden	413 45

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

• Principal Investigator: Riadh Sadik, Ass Prof, Sahlgrenska University Hospital, Gothenburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Per Hedenström, MD PhD, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT03504293
• Other Study ID Numbers: EUS-ERCP Study
• First Posted: Apr 20, 2018
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Per Hedenström, MD PhD, Sahlgrenska University Hospital, Sweden: Endosonography; Endoscopic retrograde choledochography
• Additional relevant MeSH terms: Neoplasms; Biliary Tract Neoplasms; Biliary Tract Diseases

Study Results

No Results Posted as of Dec 22, 2020