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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01408264
First received: August 2, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Chinese University of Hong Kong:

Primary Outcome Measures:
  • Post−ERCP pancreatitis [ Time Frame: 30 days after ERCP ] [ Designated as safety issue: No ]
    Reported post−ERCP pancreatitis


Secondary Outcome Measures:
  • Abdominal pain [ Time Frame: 30 days after ERCP ] [ Designated as safety issue: No ]
    Abdominal pain

  • Prolonged hospitalisation [ Time Frame: 30 days after ERCP ] [ Designated as safety issue: No ]
    Prolonged hospitalisation

  • Death [ Time Frame: 30 days after ERCP ] [ Designated as safety issue: No ]
    Death


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
Other Name: conventional 0.035 guidewire
Active Comparator: Olympus Visiglide 0.025 guidewire
Olympus Visiglide 0.025
Device: Olympus Visiglide 0.025 guidewire
0.025 guidewire
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408264

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

No publications provided

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

Additional relevant MeSH terms:
Abdominal Pain
Pancreatitis
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014