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Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography

Primary Purpose

Choledocholithiasis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopic retrograde cholangiopancreatography
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis focused on measuring endoscopic retrograde cholangiopancreatography, position

Eligibility Criteria

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

Inclusion Criteria:

  • All of followings:

    1. Any of following indications for ERCP

      ① Common bile duct stone

      ② Gallstone pancreatitis

      ③ Obstructive jaundice due to malignancy (ex. Pancreas cancer, bile duct cancer, ampulla of Vater cancer)

      ④ Common bile duct invasion metastasis of other organ malignancy (ex. Hepatocellular carcinoma with bile duct invasion, metastatic lymphadenopathy with bile duct invasion from malignancy other than pancreaticobiliary malignancy)

      ⑤ Benign biliary stricture

    2. Naïve papilla
    3. Aged over 20 years

      Exclusion Criteria:

  • Any of followings:

    1. History of endoscopic retrograde cholangiopancreatography
    2. Altered gastric and duodenal anatomy due to intra-abdominal surgery (ex. Billroth gastrectomy, total gastrectomy)
    3. Patients with severe infection or hemodynamic unstable (ex. septic shock, intubation, ventilator, inotropics)
    4. Recent myocardial infarction (within 6 months) or uncontrolled arrhythmia, unstable angina, or congestive heart failure
    5. Severe neurologic disease
    6. Patients with possible prone position (ex. severe abdominal pain, severe abdominal distension, large amount of ascites, recent intra-abdominal surgery, neck surgery, intra-abdominal catheter insertion, severe obesity)

Sites / Locations

  • Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Left lateral position

Prone position

Arm Description

Endoscopic retrograde cholangiopancreatography is performed in left lateral position in this group.

Endoscopic retrograde cholangiopancreatography is performed in prone position in this group.

Outcomes

Primary Outcome Measures

success in selective bile duct cannulation

Secondary Outcome Measures

endoscopic retrograde cholangiopancreatography-related adverse event

Full Information

First Posted
November 1, 2015
Last Updated
April 6, 2016
Sponsor
Chuncheon Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02594475
Brief Title
Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography
Official Title
A Prospective, Randomized Study Comparing Efficacy and Safety Between Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chuncheon Sacred Heart Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in diagnosis and treatment of pancreaticobiliary diseases. Traditionally, ERCP has been performed in the prone position. The prone position for ERCP can facilitate selective bile duct cannulation, offer a better fluoroscopic image of pancreaticobiliary anatomy, and prevent aspiration of gastric contents. However, in cases of difficult in the prone position, ERCP has been performed in the left lateral or supine position. Compared with the prone position, left lateral position is more comfortable for patients, especially with limitation for cervical movement including cervical cord injury, cervical spine operation, parkinson's disease, contracture due to cerebral infarction, and allow more easy passage of the scope through the pharynx, and useful to secure airway. However, in the left lateral position, it is difficult to obtain fluoroscopic image of right hepatic duct and intrahepatic bile duct. In cases of severe abdominal pain, severe abdominal distension, large amount of ascites, recent abdominal surgery or cervical spine surgery, intra-abdominal catheter insertion, severe obesity, it is difficult to position in prone or left lateral, therefore, ERCP may be performed in the supine position. In supine position for ERCP, there has been documented increased risk of cardiopulmonary adverse event and decreased success rate of selective bile duct cannulation. There have been reported the efficacy and safety between the prone position and supine position for ERCP in several studies. We aimed to evaluate the efficacy and safety between the prone position and left lateral position for ERCP in this prospective, randomized study.
Detailed Description
Methods Written informed consent for the endoscopic retrograde cholangiopancreatography is obtained from all patients. Blood culture is performed, and intravenous 3rd generation cephalosporin is administered routinely. Before endoscopic procedure, patients are randomly assigned to left lateral position or prone position for the endoscopic retrograde cholangiopancreatography. Conscious sedation is performed by non-anesthesiologist-assisted method. Intravenous midazolam 0.05-0.1 mg/kg and/or intravenous propofol 0.5mg-1mg/kg is administered. Analgesics was administered intravenous meperidine 25mg in patients with older than 50 years and meperidine 50mg in patients with younger than 50 years. To limit duodenal peristalsis hyoscine-N-butylbromide is administered intravenously. All patients are provided oxygen 2liter/minute via nasal prong. Patient's oxygen saturation, heart rate, blood pressure and respiration are monitored during procedure. Selective bile duct cannulation is performed by wire-guided cannulation method. If adverse event is occur during endoscopic procedure, it is recorded in the case report form as intra-procedural adverse event. After 4 hours, 24 hours, 2 weeks and 6 weeks of the procedure, white blood cell count, hemoglobin, platelet count, total bilirubin, aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma glutamyl transaminase, amylase, lipase, abdomen X-ray, chest X-ray are performed. Oral feeding is started with sips of water after 24 hours of endoscopic sphincterotomy and/or endoscopic papillary balloon dilation. Development of adverse event including bleeding, perforation, pancreatitis, hyperamylasemia, infection, basket impaction, cardiopulmonary adverse event, mortality are recorded according to left lateral position or prone position for the endoscopic retrograde cholangiopancreatography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis
Keywords
endoscopic retrograde cholangiopancreatography, position

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left lateral position
Arm Type
Experimental
Arm Description
Endoscopic retrograde cholangiopancreatography is performed in left lateral position in this group.
Arm Title
Prone position
Arm Type
Active Comparator
Arm Description
Endoscopic retrograde cholangiopancreatography is performed in prone position in this group.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic retrograde cholangiopancreatography
Other Intervention Name(s)
Endoscopic biliary drainge
Intervention Description
Endoscopic retrograde cholangiopancreatography is started using conventional duodenoscope (TJF 240 or 260V, Olympus Optical Co., Ltd, Tokyo, Japan) in randomly assigned left lateral position or prone position. Selective bile duct cannulation is performed using wire-guided cannulation. In case of difficult cannulation, precut is performed using a needle-knife. After selective cannulation, cholangiogram is obtained using ERCP catheter, and endoscopic sphincterotomy and/or endoscopic papillary balloon dilation is performed.
Primary Outcome Measure Information:
Title
success in selective bile duct cannulation
Time Frame
within first 1 hour after attempt of bile duct cannulation
Secondary Outcome Measure Information:
Title
endoscopic retrograde cholangiopancreatography-related adverse event
Time Frame
within 14 days after endoscopic retrograde cholangiopancreatography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All of followings: Any of following indications for ERCP ① Common bile duct stone ② Gallstone pancreatitis ③ Obstructive jaundice due to malignancy (ex. Pancreas cancer, bile duct cancer, ampulla of Vater cancer) ④ Common bile duct invasion metastasis of other organ malignancy (ex. Hepatocellular carcinoma with bile duct invasion, metastatic lymphadenopathy with bile duct invasion from malignancy other than pancreaticobiliary malignancy) ⑤ Benign biliary stricture Naïve papilla Aged over 20 years Exclusion Criteria: Any of followings: History of endoscopic retrograde cholangiopancreatography Altered gastric and duodenal anatomy due to intra-abdominal surgery (ex. Billroth gastrectomy, total gastrectomy) Patients with severe infection or hemodynamic unstable (ex. septic shock, intubation, ventilator, inotropics) Recent myocardial infarction (within 6 months) or uncontrolled arrhythmia, unstable angina, or congestive heart failure Severe neurologic disease Patients with possible prone position (ex. severe abdominal pain, severe abdominal distension, large amount of ascites, recent intra-abdominal surgery, neck surgery, intra-abdominal catheter insertion, severe obesity)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Young Park
Organizational Affiliation
Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
City
Chuncheon
State/Province
Gangwon-do
ZIP/Postal Code
200-704
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography

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