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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408264
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : July 31, 2013
Information provided by (Responsible Party):
James Yun-wong Lau, 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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

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

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

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

  2. Prolonged hospitalisation [ Time Frame: 30 days after ERCP ]
    Prolonged hospitalisation

  3. Death [ Time Frame: 30 days after ERCP ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01408264

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong Identifier: NCT01408264     History of Changes
Other Study ID Numbers: WGC
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Abdominal Pain
Pancreatic Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive