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

Primary Purpose

Abdominal Pain, Post-ERCP Acute Pancreatitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Conventional 0.035 guidewire
Olympus Visiglide 0.025 guidewire
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Endoscopy Centre, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

0.035 guidewire

Olympus Visiglide 0.025 guidewire

Arm Description

conventional 0.035 guidewire

Olympus Visiglide 0.025

Outcomes

Primary Outcome Measures

Post-ERCP pancreatitis
Reported post-ERCP pancreatitis

Secondary Outcome Measures

Abdominal pain
Abdominal pain
Prolonged hospitalisation
Prolonged hospitalisation
Death
Death

Full Information

First Posted
August 2, 2011
Last Updated
July 29, 2013
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01408264
Brief Title
A Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation
Official Title
A Prospective Randomised Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Post-ERCP Acute Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.035 guidewire
Arm Type
Active Comparator
Arm Description
conventional 0.035 guidewire
Arm Title
Olympus Visiglide 0.025 guidewire
Arm Type
Active Comparator
Arm Description
Olympus Visiglide 0.025
Intervention Type
Device
Intervention Name(s)
Conventional 0.035 guidewire
Intervention Description
0.035 guidewire
Intervention Type
Device
Intervention Name(s)
Olympus Visiglide 0.025 guidewire
Intervention Description
0.025 guidewire
Primary Outcome Measure Information:
Title
Post-ERCP pancreatitis
Description
Reported post-ERCP pancreatitis
Time Frame
30 days after ERCP
Secondary Outcome Measure Information:
Title
Abdominal pain
Description
Abdominal pain
Time Frame
30 days after ERCP
Title
Prolonged hospitalisation
Description
Prolonged hospitalisation
Time Frame
30 days after ERCP
Title
Death
Description
Death
Time Frame
30 days after ERCP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Y Lau, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Centre, Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29317269
Citation
Bassan MS, Sundaralingam P, Fanning SB, Lau J, Menon J, Ong E, Rerknimitr R, Seo DW, Teo EK, Wang HP, Reddy DN, Goh KL, Bourke MJ. The impact of wire caliber on ERCP outcomes: a multicenter randomized controlled trial of 0.025-inch and 0.035-inch guidewires. Gastrointest Endosc. 2018 Jun;87(6):1454-1460. doi: 10.1016/j.gie.2017.11.037. Epub 2018 Jan 6.
Results Reference
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A Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation

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