A Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation

Study Overview
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Brief Summary
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The aim of this study is to determine whether using a smaller wire results in a higher success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence of adverse events

Detailed Description
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Cannulation of the bile duct is a prerequisite to successful therapeutic biliary endoscopy. Cannulation itself can carry substantial risk to the patient. Acute pancreatitis following ERCP can occur up to 5% of cases. The risk increases in patients with non dilated bile ducts, young age, known past history of pancreatitis and suspected sphincter of oddi dysfunction. During the procedure of ERCP, the number of pancreatograms also correlates with incidence of post ERCP pancreatitis. Hydrostatic pressure by contrast injection into the pancreatic duct may be the principal cause of pancreatitis. We performed a meta-analysis of randomized controlled trials that compared the technique of contrast guided to wire guide cannulation in achieving bile duct cannulation during ERCP and found that wire guide cannulation was better at the prevention of post ERCP pancreatitis. The use of a guide wire obviates the need for contrast injection. The current standard is the use of a 0.035 guidewire with a hydrophilic tip. We now postulate that the use of a 0.025 further reduces post-ERCP pancreatitis as a finer wire theoretically induces less trauma to the pancreatic orifice.

Official Title
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A Prospective Randomised Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation

Conditions
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Abdominal Pain, Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Device: Conventional 0.035 guidewire
* Device: Olympus Visiglide 0.025 guidewire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients referred for ERCP who have an intact naïve papilla are considered for inclusion Exclusion Criteria: Age <18yrs Acute illness (hypotension: BP<90mmHg, hypoxia: O2 <95%, haemodynamic instability) Inability or refusal to give informed consent. Patients with previous sphincterotomy Pancreatic or ampullary cancer are excluded as post-ERCP pancreatitis (PEP) is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique. (consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla) Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.035 guidewire<br>conventional 0.035 guidewire | Device: Conventional 0.035 guidewire<br>* 0.035 guidewire<br>|
| Active Comparator: Olympus Visiglide 0.025 guidewire<br>Olympus Visiglide 0.025 | Device: Olympus Visiglide 0.025 guidewire<br>* 0.025 guidewire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP pancreatitis | Reported post-ERCP pancreatitis | 30 days after ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain | Abdominal pain | 30 days after ERCP | 
| Prolonged hospitalisation | Prolonged hospitalisation | 30 days after ERCP | 
| Death | Death | 30 days after ERCP |