Skip to content

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01408264
Enrollment
184
Registered
2011-08-03
Start date
2010-08-31
Completion date
2012-12-31
Last updated
2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Post-ERCP Acute Pancreatitis

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.

Interventions

DEVICEConventional 0.035 guidewire

0.035 guidewire

DEVICEOlympus Visiglide 0.025 guidewire

0.025 guidewire

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-ERCP pancreatitis30 days after ERCPReported post-ERCP pancreatitis

Secondary

MeasureTime frameDescription
Abdominal pain30 days after ERCPAbdominal pain
Prolonged hospitalisation30 days after ERCPProlonged hospitalisation
Death30 days after ERCPDeath

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026