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

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

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

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Device: Conventional 0.035 guidewire; Device: Olympus Visiglide 0.025 guidewire

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Endoscopy Centre, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.035 guidewire; conventional 0.035 guidewire	Device: Conventional 0.035 guidewire; 0.035 guidewire
Active Comparator: Olympus Visiglide 0.025 guidewire; Olympus Visiglide 0.025	Device: Olympus Visiglide 0.025 guidewire; 0.025 guidewire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: James Y Lau, MD, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Bassan MS, Sundaralingam P, Fanning SB, Lau J, Menon J, Ong E, Rerknimitr R, Seo DW, Teo EK, Wang HP, Reddy DN, Goh KL, Bourke MJ. The impact of wire caliber on ERCP outcomes: a multicenter randomized controlled trial of 0.025-inch and 0.035-inch guidewires. Gastrointest Endosc. 2018 Jun;87(6):1454-1460. doi: 10.1016/j.gie.2017.11.037. Epub 2018 Jan 6.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pancreatic Diseases; Abdominal Pain; Pancreatitis
• Other Study ID Numbers: WGC