Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography

Choledocholithiasis Clinical Trial

Official title:

A Prospective, Randomized Study Comparing Efficacy and Safety Between Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594475
• Other study ID #: 2015-71
• Status: Completed
• Phase: N/A
• First received: November 1, 2015
• Last updated: April 6, 2016
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• All of followings:

1. Any of following indications for ERCP

? Common bile duct stone

? Gallstone pancreatitis

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

? 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)

? 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)

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

Procedure:
• Endoscopic retrograde cholangiopancreatography
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.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine	Chuncheon	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

ASGE Standards of Practice Committee, Anderson MA, Fisher L, Jain R, Evans JA, Appalaneni V, Ben-Menachem T, Cash BD, Decker GA, Early DS, Fanelli RD, Fisher DA, Fukami N, Hwang JH, Ikenberry SO, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA. Complications of ERCP. Gastrointest Endosc. 2012 Mar;75(3):467-73. doi: 10.1016/j.gie.2011.07.010. — View Citation

ASGE Standards of Practice Committee, Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. — View Citation

Baron TH, Mallery JS, Hirota WK, Goldstein JL, Jacobson BC, Leighton JA, Waring JP, Faigel DO. The role of endoscopy in the evaluation and treatment of patients with pancreaticobiliary malignancy. Gastrointest Endosc. 2003 Nov;58(5):643-9. Review. — View Citation

Boix J, Lorenzo-Zúñiga V, Añaños F, Domènech E, Morillas RM, Gassull MA. Impact of periampullary duodenal diverticula at endoscopic retrograde cholangiopancreatography: a proposed classification of periampullary duodenal diverticula. Surg Laparosc Endosc Percutan Tech. 2006 Aug;16(4):208-11. — View Citation

Costamagna G, Shah SK, Tringali A. Current management of postoperative complications and benign biliary strictures. Gastrointest Endosc Clin N Am. 2003 Oct;13(4):635-48, ix. Review. — View Citation

Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. — View Citation

Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. Review. — View Citation

Ferreira LE, Baron TH. Comparison of safety and efficacy of ERCP performed with the patient in supine and prone positions. Gastrointest Endosc. 2008 Jun;67(7):1037-43. doi: 10.1016/j.gie.2007.10.029. Epub 2008 Jan 18. — View Citation

Froehlich F. Patient position during ERCP: prone versus supine. What about left lateral throughout? Endoscopy. 2006 Jul;38(7):755; author reply 755. — View Citation

Mulla SM, Scott IA, Jackevicius CA, You JJ, Guyatt GH. How to use a noninferiority trial: users' guides to the medical literature. JAMA. 2012 Dec 26;308(24):2605-11. doi: 10.1001/2012.jama.11235. — View Citation

Owens WD, Felts JA, Spitznagel EL Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology. 1978 Oct;49(4):239-43. — View Citation

Terruzzi V, Radaelli F, Meucci G, Minoli G. Is the supine position as safe and effective as the prone position for endoscopic retrograde cholangiopancreatography? A prospective randomized study. Endoscopy. 2005 Dec;37(12):1211-4. — View Citation

Tringali A, Mutignani M, Milano A, Perri V, Costamagna G. No difference between supine and prone position for ERCP in conscious sedated patients: a prospective randomized study. Endoscopy. 2008 Feb;40(2):93-7. Epub 2007 Dec 5. — View Citation

Williams EJ, Taylor S, Fairclough P, Hamlyn A, Logan RF, Martin D, Riley SA, Veitch P, Wilkinson M, Williamson PJ, Lombard M; BSG Audit of ERCP. Are we meeting the standards set for endoscopy? Results of a large-scale prospective survey of endoscopic retrograde cholangio-pancreatograph practice. Gut. 2007 Jun;56(6):821-9. Epub 2006 Dec 4. Erratum in: Gut. 2016 Sep;65(9):1571. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success in selective bile duct cannulation		within first 1 hour after attempt of bile duct cannulation
Secondary	endoscopic retrograde cholangiopancreatography-related adverse event		within 14 days after endoscopic retrograde cholangiopancreatography