Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography

NCT02594475 | Completed

• 1 other identifier: 2015-71
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Choledocholithiasis

Keywords

endoscopic retrograde cholangiopancreatography, position

Outcome Measures

Primary Outcomes (1)

• success in selective bile duct cannulation

  within first 1 hour after attempt of bile duct cannulation

Secondary Outcomes (1)

• endoscopic retrograde cholangiopancreatography-related adverse event

  within 14 days after endoscopic retrograde cholangiopancreatography

Study Arms (2)

Left lateral position

EXPERIMENTAL

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

Procedure: Endoscopic retrograde cholangiopancreatography

Prone position

ACTIVE COMPARATOR

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

Procedure: Endoscopic retrograde cholangiopancreatography

Interventions

Endoscopic retrograde cholangiopancreatography PROCEDURE

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.

Also known as: Endoscopic biliary drainge

Left lateral position; Prone position

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

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

Chuncheon, Gangwon-do, 200-704, South Korea

Location

Related Publications (14)

• 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. No abstract available.

  PMID: 20105473 BACKGROUND

• 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. doi: 10.1016/s0016-5107(03)01994-1.

  PMID: 14595292 BACKGROUND

• 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. doi: 10.1016/s1052-5157(03)00103-x.

  PMID: 14986791 BACKGROUND

• 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.

  PMID: 18206877 BACKGROUND

• Froehlich F. Patient position during ERCP: prone versus supine. What about left lateral throughout? Endoscopy. 2006 Jul;38(7):755; author reply 755. doi: 10.1055/s-2006-925247. No abstract available.

  PMID: 16810601 BACKGROUND

• 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. doi: 10.1055/s-2005-870511.

  PMID: 16329019 BACKGROUND

• 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. doi: 10.1055/s-2007-995317. Epub 2007 Dec 5.

  PMID: 18058651 BACKGROUND

• Williams EJ, Taylor S, Fairclough P, Hamlyn A, Logan RF, Martin D, Riley SA, Veitch P, Wilkinson M, Williamson PR, 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. doi: 10.1136/gut.2006.097543. Epub 2006 Dec 4.

  PMID: 17145737 BACKGROUND

• Owens WD, Felts JA, Spitznagel EL Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology. 1978 Oct;49(4):239-43. doi: 10.1097/00000542-197810000-00003.

  PMID: 697077 BACKGROUND

• Boix J, Lorenzo-Zuniga V, Ananos F, Domenech 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. doi: 10.1097/00129689-200608000-00002.

  PMID: 16921297 BACKGROUND

• 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. No abstract available.

  PMID: 22341094 BACKGROUND

• 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. doi: 10.1016/s0016-5107(91)70740-2.

  PMID: 2070995 BACKGROUND

• 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. No abstract available.

  PMID: 20189503 BACKGROUND

• 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.

  PMID: 23268519 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Tae Young Park

  Chuncheon Sacred Heart Hospital, Hallym University College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2015
• First Posted: November 3, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 7, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)