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In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatobiliary disease | Patients who have altered gastric anatomy who need an ERCP with an overtube for evaluation of pancreatobiliary disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography (ERCP) | Procedure | An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy |
| Measure | Description | Time Frame |
|---|---|---|
| Papilla or Duct-enterostomy Was Reached | During procedure, up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Cannulation of the Duct of Intent | Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs. | During procedure, up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have a medical indication for ERCP and have altered gastric anatomy and are referred for the procedure as part of their standard medical care will be considered for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Draganov, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands at UF Endoscoppy Center | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22817798 | Derived | Wagh MS, Draganov PV. Prospective evaluation of spiral overtube-assisted ERCP in patients with surgically altered anatomy. Gastrointest Endosc. 2012 Aug;76(2):439-43. doi: 10.1016/j.gie.2012.04.444. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Altered Gastric Anatomy | Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Altered Gastric Anatomy | Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy. |
| 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 | Papilla or Duct-enterostomy Was Reached | Posted | Number | ERCPs | During procedure, up to 3 hours | ERCP attempts | Participants |
|
|
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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 | Altered Gastric Anatomy | Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter V. Draganov | University of Florida | (352) 273-9472 | Peter.Draganov@medicine.ufl.edu |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| Successful Endoscopic Therapy |
| During procedure, up to 3 hours |
| Total Procedure Time | During procedure, up to 3 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Postsurgical anatomy | Number | participants |
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| Indications for Endoscopic Retrograde Cholangiopancreatography (ERCP) | Number | participants |
|
| ERCP attempts |
|
|
| Secondary | Successful Cannulation of the Duct of Intent | Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs. | Posted | Number | ERCPs | During procedure, up to 3 hours | ERCPs | Participants |
|
|
|
| Secondary | Successful Endoscopic Therapy | Posted | Number | ERCPs | During procedure, up to 3 hours | ERCPs | Participants |
|
|
|
| Secondary | Total Procedure Time | Posted | Mean | Full Range | minutes | During procedure, up to 3 hours | ERCPs | Participants |
|
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|
| 0 |
| 7 |
| 0 |
| 7 |
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| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |