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Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography

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ClinicalTrials.gov Identifier: NCT02594475
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
Chuncheon Sacred Heart Hospital

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.


Condition or disease Intervention/treatment Phase
Choledocholithiasis Procedure: Endoscopic retrograde cholangiopancreatography Not Applicable

Detailed Description:

Methods

  1. Written informed consent for the endoscopic retrograde cholangiopancreatography is obtained from all patients.
  2. Blood culture is performed, and intravenous 3rd generation cephalosporin is administered routinely.
  3. Before endoscopic procedure, patients are randomly assigned to left lateral position or prone position for the endoscopic retrograde cholangiopancreatography.
  4. 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.
  5. All patients are provided oxygen 2liter/minute via nasal prong. Patient's oxygen saturation, heart rate, blood pressure and respiration are monitored during procedure.
  6. 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.
  7. 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.
  8. Oral feeding is started with sips of water after 24 hours of endoscopic sphincterotomy and/or endoscopic papillary balloon dilation.
  9. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing Efficacy and Safety Between Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography
Study Start Date : August 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Left lateral position
Endoscopic retrograde cholangiopancreatography is performed in left lateral position in this group.
Procedure: Endoscopic retrograde cholangiopancreatography
  1. 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.
  2. Selective bile duct cannulation is performed using wire-guided cannulation.
  3. In case of difficult cannulation, precut is performed using a needle-knife.
  4. After selective cannulation, cholangiogram is obtained using ERCP catheter, and endoscopic sphincterotomy and/or endoscopic papillary balloon dilation is performed.
Other Name: Endoscopic biliary drainge

Active Comparator: Prone position
Endoscopic retrograde cholangiopancreatography is performed in prone position in this group.
Procedure: Endoscopic retrograde cholangiopancreatography
  1. 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.
  2. Selective bile duct cannulation is performed using wire-guided cannulation.
  3. In case of difficult cannulation, precut is performed using a needle-knife.
  4. After selective cannulation, cholangiogram is obtained using ERCP catheter, and endoscopic sphincterotomy and/or endoscopic papillary balloon dilation is performed.
Other Name: Endoscopic biliary drainge




Primary Outcome Measures :
  1. success in selective bile duct cannulation [ Time Frame: within first 1 hour after attempt of bile duct cannulation ]

Secondary Outcome Measures :
  1. endoscopic retrograde cholangiopancreatography-related adverse event [ Time Frame: within 14 days after endoscopic retrograde cholangiopancreatography ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594475


Locations
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Korea, Republic of
Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
Chuncheon, Gangwon-do, Korea, Republic of, 200-704
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
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Study Director: Tae Young Park Chuncheon Sacred Heart Hospital, Hallym University College of Medicine

Publications:

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Responsible Party: Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02594475     History of Changes
Other Study ID Numbers: 2015-71
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chuncheon Sacred Heart Hospital:
endoscopic retrograde cholangiopancreatography, position

Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis