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

NCT03140007 | Unknown

• 1 other identifier: AIG-002
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Cholangiocarcinoma; Biliary Stricture

Keywords

ERCP; cholangioscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of cholangioscopy or cholangiography

  Malignancy will be determined by cytology or histology on tissue sampling during the index procedure, or from other tissue acquisition or surgical specimen histopathology up to 6 months after the index procedure.The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure. • Overall diagnostic accuracy will be assessed for ERCP impression of malignancy, ERCP-guided brushing and biopsies separately and combined, SpyDS impression of malignancy and SpyBite biopsies

  6 Months

Secondary Outcomes (8)

• Occurrence and severity of procedure related serious adverse events

  30 days

• Technical success of procedure

  30 days

• Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value.

  6 months

• Impact of ERCP or cholangioscopy on patient management.

  6 months

• Number of patients needed additional diagnostic procedures beyond the index procedure for final diagnosis

  6 months

Study Arms (2)

Control arm - ERCP arm

OTHER

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

Device: ERCP guided brushing and biopsy

Study arm - cholangioscopy arm

ACTIVE COMPARATOR

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.

Device: single operator cholangioscopy

Interventions

single operator cholangioscopy DEVICE

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.

Study arm - cholangioscopy arm

ERCP guided brushing and biopsy DEVICE

• If patients are randomized to the Control arm, then they will undergo an ERCP. ERCP-based impression of malignancy (yes/no/indeterminate) will be recorded. ERCP-guided brushing and ERCP-guided biopsy will be performed.

Control arm - ERCP arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Evangelisches Krankenhaus Düsseldorf: collaborator

Related Publications (1)

• Gerges 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 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mohan Ramchandani, MD DM

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Ramchandani, MD DM

CONTACT

9701335444; ramchandanimohan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: prospective, multi-center, randomized controlled, post market study
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Model Details: prospective, multi-center, randomized controlled, post market study

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 4, 2017
• Study Start: June 15, 2017
• Primary Completion: February 15, 2018
• Study Completion: June 15, 2018
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share