Trial Outcomes & Findings for Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation (NCT NCT05600270)
NCT ID: NCT05600270
Last Updated: 2024-10-31
Results Overview
Rate of successful cannulation of common bile duct
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Day of Procedure
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
Angled Wire
Angled guidewire intervention arm
Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP
|
Straight Wire
Straight guidewire intervention arm
Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Angled Wire
n=33 Participants
Angled guidewire intervention arm
Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP
|
Straight Wire
n=33 Participants
Straight guidewire intervention arm
Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.42 years
n=33 Participants
|
60.66 years
n=33 Participants
|
68.18 years
n=66 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=33 Participants
|
17 Participants
n=33 Participants
|
29 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=33 Participants
|
16 Participants
n=33 Participants
|
37 Participants
n=66 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day of ProcedureRate of successful cannulation of common bile duct
Outcome measures
| Measure |
Angled Wire
n=33 Participants
Angled guidewire intervention arm
Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP
|
Straight Wire
n=33 Participants
Straight guidewire intervention arm
Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP
|
|---|---|---|
|
Cannulation
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Procedure day and up to day 5 post procedureNumber of participants who develop post ERCP pancreatitis
Outcome measures
| Measure |
Angled Wire
n=33 Participants
Angled guidewire intervention arm
Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP
|
Straight Wire
n=33 Participants
Straight guidewire intervention arm
Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP
|
|---|---|---|
|
Post ERCP Pancreatitis
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day of procedureTotal duration of procedure
Outcome measures
| Measure |
Angled Wire
n=33 Participants
Angled guidewire intervention arm
Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP
|
Straight Wire
n=33 Participants
Straight guidewire intervention arm
Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP
|
|---|---|---|
|
Duration
|
1964.26 seconds
Interval 557.0 to 8520.0
|
1569.03 seconds
Interval 711.0 to 4368.0
|
Adverse Events
Angled Wire
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Straight Wire
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Angled Wire
n=33 participants at risk
Angled guidewire intervention arm
Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP
|
Straight Wire
n=33 participants at risk
Straight guidewire intervention arm
Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP
|
|---|---|---|
|
Gastrointestinal disorders
Perforation
|
0.00%
0/33 • Randomization on day of procedure to post procedure day 5
|
0.00%
0/33 • Randomization on day of procedure to post procedure day 5
|
|
Gastrointestinal disorders
Bleeding
|
0.00%
0/33 • Randomization on day of procedure to post procedure day 5
|
0.00%
0/33 • Randomization on day of procedure to post procedure day 5
|
|
Infections and infestations
Post ERCP Cholangitis
|
0.00%
0/33 • Randomization on day of procedure to post procedure day 5
|
0.00%
0/33 • Randomization on day of procedure to post procedure day 5
|
|
Gastrointestinal disorders
post ERCP Pancreatitis
|
3.0%
1/33 • Number of events 1 • Randomization on day of procedure to post procedure day 5
|
6.1%
2/33 • Number of events 2 • Randomization on day of procedure to post procedure day 5
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place