Bile Duct Diseases
Conditions
Keywords
ERCP
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAngled guidewire
Cannulation of the common bile duct using an angled-tip guidewire during ERCP
DEVICEStraight guidewire
Cannulation of the common bile duct using an straight-tip guidewire during ERCP
Sponsors
Neev Mehta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single-blinded study with masking of participant
Intervention model description
Randomized, Controlled, Single-Blinded Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct * patients undergoing ERCP for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement)
Exclusion criteria
* Patients who are less than 18 years old * Pregnant patients * Patients who have undergone previous bile duct cannulation or sphincterotomy * Patients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomy * Patients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric bypass) * Patients with acute pancreatitis * Patients who refuse endoscopic intervention * Patients with ampullary tumor, duodenal stenosis, or pre-operatively proven pancreaticobiliary malunion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannulation | Day of Procedure | Rate of successful cannulation of common bile duct |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post ERCP Pancreatitis | Procedure day and up to day 5 post procedure | Number of participants who develop post ERCP pancreatitis |
| Duration | Day of procedure | Total duration of procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Angled Wire Angled guidewire intervention arm
Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP | 33 |
| Straight Wire Straight guidewire intervention arm
Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Angled Wire | Straight Wire | Total |
|---|---|---|---|
| Age, Continuous | 70.42 years | 60.66 years | 68.18 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 29 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 1 / 33 | 2 / 33 |
Outcome results
Primary
Cannulation
Rate of successful cannulation of common bile duct
Time frame: Day of Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Angled Wire | Cannulation | 30 Participants |
| Straight Wire | Cannulation | 31 Participants |
Secondary
Duration
Total duration of procedure
Time frame: Day of procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Angled Wire | Duration | 1964.26 seconds |
| Straight Wire | Duration | 1569.03 seconds |
Secondary
Post ERCP Pancreatitis
Number of participants who develop post ERCP pancreatitis
Time frame: Procedure day and up to day 5 post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Angled Wire | Post ERCP Pancreatitis | 1 Participants |
| Straight Wire | Post ERCP Pancreatitis | 2 Participants |