Clinical trial NCT02594475: 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
Overall status: COMPLETED
Phase: NA
Conditions: Choledocholithiasis
Keywords: endoscopic retrograde cholangiopancreatography, position
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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)

Primary outcomes:
measure: success in selective bile duct cannulation
timeFrame: within first 1 hour after attempt of bile duct cannulation
Secondary outcomes:
measure: endoscopic retrograde cholangiopancreatography-related adverse event
timeFrame: within 14 days after endoscopic retrograde cholangiopancreatography
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
state: Gangwon-do
Study officials:
affiliation: Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
name: Tae Young Park
role: STUDY_DIRECTOR
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