ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

biliary pathology

anatomic abnormality

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

During procedure, at the time of cannulation

Secondary outcome [1]

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]

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?

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]

Italy

State/province [1]

Sicily

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

University of Palermo

Address [1]

Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

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

Dr Girolamo Geraci

Address

University of Palermo
Section of General and Thoracic Surgery
Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy

Country

Italy

Phone

+39916552773

Fax

+39916552774

girolamo.geraci@unipa.it

Contact person for public queries

Name

Girolamo Geraci

Address

University of Palermo
Section of General and Thoracic Surgery
Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy

Country

Italy

Phone

+39916552773

Fax

+39916552774

girolamo.geraci@unipa.it

Contact person for scientific queries

Name

Girolamo Geraci

Address

University of Palermo
Section of General and Thoracic Surgery
Via Liborio Giuffre, 5
POSTAL CODE: 90127
Palermo, Sicily, Italy

Country

Italy

Phone

+39916552773

Fax

+39916552774

girolamo.geraci@unipa.it

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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