Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.

NCT ID: NCT04503200

Last Updated: 2020-08-07

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2022-08-30

Brief Summary

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Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.

Detailed Description

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Conditions

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Endoscopic Retrograde Cholangiopancreatography Common Bile Duct Diseases Transpancreatic Precut Precut Double Guidewire

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Double guidewire

Group Type ACTIVE_COMPARATOR

Double guidewire

Intervention Type PROCEDURE

After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.

Transpancreatic precut

Group Type ACTIVE_COMPARATOR

Transpancreatic precut

Intervention Type PROCEDURE

After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.

Interventions

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Double guidewire

After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.

Intervention Type PROCEDURE

Transpancreatic precut

After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* unintentional cannulation of the pancreatic duct 3 times
* Consenting to join the study

Exclusion Criteria

* Previous ERCP with or without previous sphincterotomy
* Known coagulopathy

* \- Pregnancy
* \- Known acute pancreatitis at the time of procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hany Shehab

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hany M Shehab

Role: STUDY_CHAIR

Kasr-Elaini Faculty of Medicine

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hany Shehab

Role: CONTACT

01111111071

Facility Contacts

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Hany M Shehab, MD

Role: primary

01111111071

Other Identifiers

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DGWRCT

Identifier Type: -

Identifier Source: org_study_id

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