This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong Identifier:
First received: August 2, 2011
Last updated: July 29, 2013
Last verified: July 2013
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

Condition Intervention Phase
Abdominal Pain Post-ERCP Acute Pancreatitis Device: Conventional 0.035 guidewire Device: Olympus Visiglide 0.025 guidewire Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation

Resource links provided by NLM:

Further study details as provided by James Yun-wong Lau, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Post−ERCP pancreatitis [ Time Frame: 30 days after ERCP ]
    Reported post−ERCP pancreatitis

Secondary Outcome Measures:
  • Abdominal pain [ Time Frame: 30 days after ERCP ]
    Abdominal pain

  • Prolonged hospitalisation [ Time Frame: 30 days after ERCP ]
    Prolonged hospitalisation

  • Death [ Time Frame: 30 days after ERCP ]

Enrollment: 184
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01408264

Endoscopy Centre, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: James Y Lau, MD Chinese University of Hong Kong
  More Information

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong Identifier: NCT01408264     History of Changes
Other Study ID Numbers: WGC
Study First Received: August 2, 2011
Last Updated: July 29, 2013

Additional relevant MeSH terms:
Abdominal Pain
Pancreatic Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on September 21, 2017