Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000415707
Ethics application status
Approved
Date submitted
3/04/2013
Date registered
15/04/2013
Date last updated
15/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intradiverticular ampulla of Vater: personal experience at endoscopic retrograde cholangiopancreatography (ERCP).
Scientific title
In adult with biliary pathology, is the presence of intradiverticular ampulla of Vater, retrospectively compared with normal ampulla of Vater, is responsible for higher incidence of technical failure of endoscopic retrograde cholangiopancreatography (ERCP)?
Secondary ID [1] 282240 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
biliary pathology 288758 0
anatomic abnormality 288759 0
Condition category
Condition code
Oral and Gastrointestinal 289115 289115 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective evaluation of patients with biliary pathology related to intradiverticular ampulla of Vater visualized at endoscopic retrograde cholangiopancreatography (ERCP).
The aim of this study is to evaluate the success rate, difficult cannulation and complication rate between patients with and without intradiverticular ampulla of Vater, as well as to identify any independent factor that may influence the difficulty in cannulation. The duration of observation is 1 year.
All the procedures were performed by the same skilled team. All patients received a combination of midazolam and fentanyl, on escalating dosing according to the needs for conscious sedation. Supplemental oxygen was also given trans-nasally during the entire procedure.
The patients were only observed at the time of ERCP, the successive follow-up was only clinic and laboratoristic at 1, 6 and 12 months after ERCP.
Intervention code [1] 286850 0
Not applicable
Comparator / control treatment
The aim of this study is to evaluate the success rate, difficult cannulation and complication rate between patients with and without IA, as well as to identify any independent factor that may influence the difficulty in cannulation. The duration of follow up in each patients is 1 year. The period of historical data collection is January 2008 - December 2012 (500 consecutive patients underwent endoscopic retrograde cholangiopancreatography; data were obtained from University Hospital of Palermo informatic database).
Control group
Historical

Outcomes
Primary outcome [1] 289227 0
Biliary cannulation was attempted by using a standard three-lumen sphincterotome. Cannulation was considered successful when the sphincterotome or the ERCP catheter was inserted deeply into the common bile duct and a cholangiogram was obtained. Difficult of deep cannulation was defined according to the Boix and coworkers classification.
Sphincterotomy was performed with an endo-cut mode.
All the data were registered in a database.
We considered primary outcome success rate of biliary deep cannulation.
Timepoint [1] 289227 0
During procedure, at the time of cannulation
Secondary outcome [1] 302075 0
Complication at ERCP: postoperative cholangitis, pancreatitis; duodenal perforation, ampullary bleeding.
All the complication were identified, registered and evaluated to solve in endoscopic room or in operatory theatre.
Timepoint [1] 302075 0
During the procedure

Eligibility
Key inclusion criteria
500 consecutive patients underwent endoscopic retrograde cholangiopancreatography: in the control group are the patients underwent endoscopic retrograde cholangiopancreatography with normal ampulla of Vater
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous biliary surgery, previous biliary sphincterotomy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/01/2008
Actual
7/01/2008
Date of last participant enrolment
Anticipated
Actual
20/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 4968 0
Italy
State/province [1] 4968 0
Sicily

Funding & Sponsors
Funding source category [1] 287003 0
Hospital
Name [1] 287003 0
University of Palermo
Country [1] 287003 0
Italy
Primary sponsor type
University
Name
University of Palermo
Address
Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy
Country
Italy
Secondary sponsor category [1] 285787 0
None
Name [1] 285787 0
none
Address [1] 285787 0
none
Country [1] 285787 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Introduction: Intradiverticular ampulla (IA) is found in 9% to 32% of patients undergoing endoscopic retrograde cholagiopancreatography (ERCP). Contradictory results have been reported in the literature with regard to the true impact of IA on the technical success and complication rate of ERCP.
Objective: The aim of this study is to evaluate the success rate, difficult cannulation and complication rate between patients with and without IA, as well as to identify any independent factor that may influence the difficulty in cannulation.
Design: A retrospective study.
Setting: University Hospital of Palermo. Section of General and Thoracic Surgery. Division of Surgical Endoscopy.
Patients: A total of 500 consecutive patients who underwent ERCP were divided into 2 groups according to the presence (group A, 81 patients) or absence (group B, 419 patients) of IA.
Results: Successful cannulation was achieved in 100% of group A patients compared to 98% of group B patients (p = ns). There was a significant difference (p < 0.05) in the type of cannulation, that was routinary in group B while required guide-wire or special sphincterotome in group A (p < 0.05). Cholangitis (p < 0.05), microstone, stone recurrence (p < 0.05), normal cholangiogram (p < 0.005) and transient hyperamylasemia (p < 0.005) were more frequently observed among group A patients. There was no significant difference in complication rate between both the groups.
Conclusions: IA becomes more frequent with ageing and is a risk factor for biliary stone disease. IA is also associated with post-ERCP transient hyperamylasemia and biliary stone recurrence. The finding of an IA at ERCP should not be considered a predictor for failed cannulation. In fact, it may indicate an easier cannulation attempt in selected cases, provided that the papilla can be found with confidence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38978 0
Dr Girolamo Geraci
Address 38978 0
University of Palermo
Section of General and Thoracic Surgery
Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy
Country 38978 0
Italy
Phone 38978 0
+39916552773
Fax 38978 0
+39916552774
Email 38978 0
[email protected]
Contact person for public queries
Name 38979 0
Girolamo Geraci
Address 38979 0
University of Palermo
Section of General and Thoracic Surgery
Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy
Country 38979 0
Italy
Phone 38979 0
+39916552773
Fax 38979 0
+39916552774
Email 38979 0
[email protected]
Contact person for scientific queries
Name 38980 0
Girolamo Geraci
Address 38980 0
University of Palermo
Section of General and Thoracic Surgery
Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy
Country 38980 0
Italy
Phone 38980 0
+39916552773
Fax 38980 0
+39916552774
Email 38980 0
[email protected]

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