Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02548884

Enrollment

1190

Registered

2015-09-14

Start date

2015-09-30

Completion date

2020-12-30

Last updated

2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Retrograde Cholangiopancreatography

Brief summary

The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .

Interventions

PROCEDUREBiliary cannulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Naive papilla, ERCP indication common bile duct cannulation

Exclusion criteria

* No consent to the study * Ongoing pancreatitis

Design outcomes

Primary

Measure	Time frame	Description
Post ERCP pancreatitis defined by ESGE guidelines published 2014	48 hours	Acute pancreatitis within 48 hours post ERCP. Post-ERCP pancreatitis (PEP) is defined as the presence of abdominal pain attributable to acute pancreatitis, together with a need for an unplanned hospitalization or an extension of a planned hospitalization by at least 2 days, and a serum /plasma amylase at least 3 times above the upper limit of normal at 24 hours after the procedure.

Secondary

Measure	Time frame	Description
Biliary cannulation success within 15 minutes after randomization	15 minutes	After randomization, timing to get the wire in biliary duct. First assessed the number of procedures succeeded in 15 minutes.
Biliary cannulation success, total number	2 hours	The total number of successful biliary cannulations after randomization

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026