Trial Outcomes & Findings for Evaluation of the Impact of a Forward Viewing Scope at Time of ERCP (NCT NCT05627882)
NCT ID: NCT05627882
Last Updated: 2026-03-02
Results Overview
Endoscopic findings that alter medical/procedural management including: erosive disease, Barrett's esophagus, peptic ulcer, gastrointestinal malignancy, other.
Recruitment status
COMPLETED
Target enrollment
163 participants
Primary outcome timeframe
Intra-procedural, up to 2 hours post-procedure
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
Standard Endoscopic Retrograde Cholangiopancreatography (ERCP)
Patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with standard side viewing scope
Forward viewing endoscope: Additional examination with standard forward viewing endoscope
|
|---|---|
|
Overall Study
STARTED
|
163
|
|
Overall Study
COMPLETED
|
163
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Impact of a Forward Viewing Scope at Time of ERCP
Baseline characteristics by cohort
| Measure |
Standard ERCP
n=163 Participants
Patients undergoing ERCP with standard side viewing scope
Forward viewing endoscope: Additional examination with standard forward viewing endoscope
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
83 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=41 Participants
|
|
Anticoagulation
Taking Anticoagulants
|
39 Participants
n=41 Participants
|
|
Anticoagulation
Not Taking Anticoagulants
|
124 Participants
n=41 Participants
|
|
Surgically Altered Anatomy
Normal Anatomy
|
156 Participants
n=41 Participants
|
|
Surgically Altered Anatomy
Surgically Altered Anatomy
|
7 Participants
n=41 Participants
|
|
Cardiovascular Disease
Cardiac Disease
|
90 Participants
n=41 Participants
|
|
Cardiovascular Disease
No Cardiac Disease
|
73 Participants
n=41 Participants
|
|
Renal Disease
Renal Disease
|
15 Participants
n=41 Participants
|
|
Renal Disease
No Renal Disease
|
148 Participants
n=41 Participants
|
|
Liver Disease
Liver Disease
|
29 Participants
n=41 Participants
|
|
Liver Disease
No Liver Disease
|
134 Participants
n=41 Participants
|
|
Malignancy
History of Malignancy
|
92 Participants
n=41 Participants
|
|
Malignancy
No History of Malignancy
|
71 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Intra-procedural, up to 2 hours post-procedurePopulation: Patients with differences found on Forward Viewing Scope
Endoscopic findings that alter medical/procedural management including: erosive disease, Barrett's esophagus, peptic ulcer, gastrointestinal malignancy, other.
Outcome measures
| Measure |
Standard ERCP
n=69 Participants
Patients undergoing ERCP with standard side viewing scope
Forward viewing endoscope: Additional examination with standard forward viewing endoscope
|
|---|---|
|
Number of Participants With Clinically Significant Endoscopic Findings
|
37 Participants
|
SECONDARY outcome
Timeframe: Intra-procedural, up to 2 hours post-procedurePopulation: Patients with differences found on Forward Viewing Scope
Endoscopic findings that do not alter medical/procedural management including: gastritis, diverticulum, and hiatal hernia
Outcome measures
| Measure |
Standard ERCP
n=69 Participants
Patients undergoing ERCP with standard side viewing scope
Forward viewing endoscope: Additional examination with standard forward viewing endoscope
|
|---|---|
|
Number of Participants With Non-clinically Significant Endoscopic Findings
|
32 Participants
|
Adverse Events
Standard 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place