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Completed

NCT Number: NCT01598142

Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.

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Key information

Conditions

Biliary Diseases Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Pancreas Diseases Pancreatic Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

About this study

A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP

Exclusion criteria

  • previous endoscopic sphincterotomy,
  • surgically altered anatomy (e.g. Billroth II gastrectomy) or
  • diagnostic duodenoscopy

Treatment and study plan

Team 1

Procedure

experienced endoscopist with a experienced assistant

Other names: experienced

Team 2

Procedure

same experienced endoscopist with a new trained assistant

Other names: new trained

Primary outcomes

  1. Cannulation success rate

    Time frame: two years

Secondary outcomes

  1. Incidences of post-ERCP pancreatitis

    Time frame: two years

  2. Incidences of bleeding

    Time frame: two years

  3. Incidences of perforation

    Time frame: two years

  4. Incidences of infection

    Time frame: two years

  5. Number of attempts at cannulation

    Time frame: two years

  6. Cannulation time

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Qi-yong Li

Other

Registry information

Official study title

Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
May 15, 2012
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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