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

Phase 4

Completed

• Conditions: Abdominal Pain; Post-ERCP Acute Pancreatitis
• Interventions: Device: Conventional 0.035 guidewire; Device: Olympus Visiglide 0.025 guidewire

• Registration Number: NCT01408264
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• All patients referred for ERCP who have an intact naïve papilla are considered for inclusion

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.035 guidewire	Conventional 0.035 guidewire	conventional 0.035 guidewire
Olympus Visiglide 0.025 guidewire	Olympus Visiglide 0.025 guidewire	Olympus Visiglide 0.025

Primary Outcome Measures

Name	Time	Method
Post-ERCP pancreatitis	30 days after ERCP	Reported post-ERCP pancreatitis

Secondary Outcome Measures

Name	Time	Method
Abdominal pain	30 days after ERCP	Abdominal pain
Prolonged hospitalisation	30 days after ERCP	Prolonged hospitalisation
Death	30 days after ERCP	Death

Trial Locations

Locations (1)

Endoscopy Centre, Prince of Wales Hospital; 🇨🇳 Hong Kong, China