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

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408264
• Other study ID #: WGC
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2011
• Last updated: July 29, 2013
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Device:
• Conventional 0.035 guidewire
0.035 guidewire
• Olympus Visiglide 0.025 guidewire
0.025 guidewire

Locations

Country	Name	City	State
China	Endoscopy Centre, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP pancreatitis	Reported post-ERCP pancreatitis	30 days after ERCP	No
Secondary	Abdominal pain	Abdominal pain	30 days after ERCP	No
Secondary	Prolonged hospitalisation	Prolonged hospitalisation	30 days after ERCP	No
Secondary	Death	Death	30 days after ERCP	No