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

NCT ID: NCT01408264

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Abdominal Pain Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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0.035 guidewire

conventional 0.035 guidewire

Group Type ACTIVE_COMPARATOR

Conventional 0.035 guidewire

Intervention Type DEVICE

0.035 guidewire

Olympus Visiglide 0.025 guidewire

Olympus Visiglide 0.025

Group Type ACTIVE_COMPARATOR

Olympus Visiglide 0.025 guidewire

Intervention Type DEVICE

0.025 guidewire

Interventions

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Conventional 0.035 guidewire

0.035 guidewire

Intervention Type DEVICE

Olympus Visiglide 0.025 guidewire

0.025 guidewire

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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James Yun-wong Lau

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Y Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Endoscopy Centre, Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29317269 (View on PubMed)

Other Identifiers

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WGC

Identifier Type: -

Identifier Source: org_study_id