Trial Outcomes & Findings for The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders (NCT NCT00861198)

Results Overview

Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings.

Recruitment status

COMPLETED

Target enrollment

88 participants

Primary outcome timeframe

baseline

Results posted on

2015-07-27

Participant Flow

There were 88 participants who were enrolled into the study; however, 13 were excluded because they did not qualify for the SpyGlass examination.

Participant milestones

Participant milestones
Measure	ERCP With Cholangioscopy and/or Pancretoscopy Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
Overall Study STARTED	75
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	ERCP With Cholangioscopy and/or Pancretoscopy Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
Overall Study SpyGlass Failed	5

Baseline Characteristics

The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ERCP With Cholangioscopy and/or Pancretoscopy n=75 Participants Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings.

Outcome measures

Outcome measures
Measure	ERCP With Cholangioscopy and/or Pancretoscopy n=75 Participants Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
Successful Procedure Completion Successful completion	70 participants
Successful Procedure Completion Unsuccessful/Failed	5 participants

Adverse Events

ERCP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter V. Draganov

University of Florida

Phone: (352) 273-9472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place