Clinical trial · Interventional

Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic .

Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic - a Randomized Controlled Study

NCT03140007CI-TRIAL-00027409CholangioscopyunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and brushing in patients with indeterminate biliary strictures in the setting of cholangiocarcinoma.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Biliary Stricture	—	UNRESOLVED	—
Cholangiocarcinoma	Cholangiocarcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
ERCP guided brushing and biopsy	Device	—	UNRESOLVED
single operator cholangioscopy	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
OTHER
label
Control arm - ERCP arm
description
Control arm- If a patient is randomized to the Control arm, then the procedure will consist of the following: ERC with recording of ERC-based impression of malignancy .ERC-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The biopsy forceps / brush will be selected per investigator preference. ERC-guided brushing will be performed, consisting of 10 through-and-fro passes through the target lesion. After this a biliary stent will be placed under ERC-guidance if needed. A biliary sphincterotomy will be performed as needed
interventionNames
1. Device: ERCP guided brushing and biopsy
type
ACTIVE_COMPARATOR
label
Study arm - cholangioscopy arm
description
If patient is randomized to the Study arm, then the procedure will consist of the following in order: Cannulation and sphincterotomy per standard of practice. POCS with recording of POCS-based impression of malignancy (yes/no/indeterminate). POCS will be performed using the Spy DS system. POCS-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The POCS-guided biopsy forceps will be the SpyBite forceps.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age 18 or older.
2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study
3. Biliary obstructive symptoms
4. Indeterminate biliary stricture suspected to be intrinsic based on prior imaging

Exclusion Criteria:

1. Contraindications for endoscopic techniques
2. Prior ERCP for assessment of indeterminate biliary stricture
3. Pancreatic head mass identified on prior non-invasive imaging and thought to be the cause of the biliary obstructive symptoms

References

Publications (1)

DERIVEDGerges C, Beyna T, Tang RSY, Bahin F, Lau JYW, van Geenen E, Neuhaus H, Nageshwar Reddy D, Ramchandani M. Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video). Gastrointest Endosc. 2020 May;91(5):1105-1113. doi: 10.1016/j.gie.2019.11.025. Epub 2019 Nov 25. PMID 31778656