An interventional study of Angled guidewire and Straight guidewire in Bile Duct Diseases, sponsored by Neev Mehta. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Neev Mehta · Not applicable, Interventional, and Treatment
The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.
Wire-guided cannulation of the common bile duct is a standard technique utilized during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. The investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. The investigators hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary cannulation during ERCP.
56 studies on the registry are indexed under Bile Duct Diseases; 16 are open to participants now.
This study's enrollment of 70 is below the median of 93 across 34 interventional studies indexed under Bile Duct Diseases.
Browse Bile Duct Diseases studies →This is the only study on the registry with Neev Mehta as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Angled guidewire intervention arm
Device: Angled guidewire
Straight guidewire intervention arm
Device: Straight guidewire
Cannulation of the common bile duct using an angled-tip guidewire during ERCP
Cannulation of the common bile duct using an straight-tip guidewire during ERCP
Cannulation
Rate of successful cannulation of common bile duct
Time frame: Day of Procedure
Post ERCP Pancreatitis
Number of participants who develop post ERCP pancreatitis
Time frame: Procedure day and up to day 5 post procedure
Duration
Total duration of procedure
Time frame: Day of procedure
| Milestone | Angled Wire | Straight Wire |
|---|---|---|
| Started | 33 | 33 |
| Completed | 33 | 33 |
| Not completed | 0 | 0 |
Rate of successful cannulation of common bile duct
| Participants | Angled Wire | Straight Wire |
|---|---|---|
| Cannulation | 30 | 31 |
Number of participants who develop post ERCP pancreatitis
| Participants | Angled Wire | Straight Wire |
|---|---|---|
| Post ERCP Pancreatitis | 1 | 2 |
Total duration of procedure
| seconds | Angled Wire | Straight Wire |
|---|---|---|
| Duration | 1964.26 (557 to 8520) | 1569.03 (711 to 4368) |
Collected over Randomization on day of procedure to post procedure day 5. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Angled Wire | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) |
| Straight Wire | 0/33 (0%) | 2/33 (6.1%) | 0/33 (0%) |
| Event | Angled Wire | Straight Wire |
|---|---|---|
| post ERCP PancreatitisGastrointestinal disorders | 1/33 | 2/33 |
| PerforationGastrointestinal disorders | 0/33 | 0/33 |
| BleedingGastrointestinal disorders | 0/33 | 0/33 |
| Post ERCP CholangitisInfections and infestations | 0/33 | 0/33 |
| Age, Continuous(years) | Angled Wire | Straight Wire | Total |
|---|---|---|---|
| Mean | 70.42 (33 to 93) | 60.66 (31 to 96) | 68.18 (31 to 96) |
| Sex: Female, Male(Participants) | Angled Wire | Straight Wire | Total |
|---|---|---|---|
| Female | 12 | 17 | 29 |
| Male | 21 | 16 | 37 |
| Race and Ethnicity Not Collected(Participants) | Angled Wire | Straight Wire | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No
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