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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angled wire | Active Comparator | Angled guidewire intervention arm |
|
| Straight wire | Active Comparator | Straight guidewire intervention arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angled guidewire | Device | Cannulation of the common bile duct using an angled-tip guidewire during ERCP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cannulation | Rate of successful cannulation of common bile duct | Day of Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post ERCP Pancreatitis | Number of participants who develop post ERCP pancreatitis | Procedure day and up to day 5 post procedure |
| Duration | Total duration of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Marie Joyce, MD | Lahey Hospital & Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23250671 | Background | Vihervaara H, Gronroos JM, Koivisto M, Gullichsen R, Salminen P. Angled- or straight-tipped hydrophilic guidewire in biliary cannulation: a prospective, randomized, controlled trial. Surg Endosc. 2013 Apr;27(4):1281-6. doi: 10.1007/s00464-012-2596-6. Epub 2012 Dec 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Angled Wire | Angled guidewire intervention arm Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP |
| FG001 | Straight Wire | Straight guidewire intervention arm Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Angled Wire | Angled guidewire intervention arm Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP |
| BG001 | Straight Wire | Straight guidewire intervention arm Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cannulation | Rate of successful cannulation of common bile duct | Posted | Count of Participants | Participants | Day of Procedure |
|
Randomization on day of procedure to post procedure day 5
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Angled Wire | Angled guidewire intervention arm Angled guidewire: Cannulation of the common bile duct using an angled-tip guidewire during ERCP |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neev Mehta | Lahey Hospital and Medical Center | 781-744-1933 | neev.n.mehta@lahey.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2022 | Oct 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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Randomized, Controlled, Single-Blinded Trial
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Single-blinded study with masking of participant
| Straight guidewire | Device | Cannulation of the common bile duct using an straight-tip guidewire during ERCP |
|
| Day of procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Post ERCP Pancreatitis | Number of participants who develop post ERCP pancreatitis | Posted | Count of Participants | Participants | Procedure day and up to day 5 post procedure |
|
|
|
| Secondary | Duration | Total duration of procedure | Posted | Mean | Full Range | seconds | Day of procedure |
|
|
|
| 0 |
| 33 |
| 1 |
| 33 |
| 0 |
| 33 |
| EG001 | Straight Wire | Straight guidewire intervention arm Straight guidewire: Cannulation of the common bile duct using an straight-tip guidewire during ERCP | 0 | 33 | 2 | 33 | 0 | 33 |
| Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Post ERCP Cholangitis | Infections and infestations | Systematic Assessment |
|
| post ERCP Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
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