Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction

NCT03054987 | Completed

• 1 other identifier: 758636
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the rates of adverse events between patients undergoing Endoscopic Ultrasound- guided biliary drainage and Endoscopic Retrograde Cholangiopancreatography for distal malignant biliary obstruction.

Conditions

Pancreatic Cancer; Pancreatic Neoplasms; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (11)

• Rates of perforation

  As defined by evidence of air or luminal contents outside the GI tract

  1 week

• Rates of pancreatitis

  Defined as typical pain with amylase/lipase \>3 times normal

  1 week

• Rates of bile leak

  Not caused by pancreatitis or perforation

  1 week

• Rates of bleeding

  As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503

  1 week

• Rates of infection (cholangitis)

  As defined by \>38C \>24 hours with cholestasis

  1 week

• Rates of peritionitis

  As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503

  1 week

• Rates of cholecystitis

  As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503

  1 week

• Rates of pneumoperitoneum

  As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503

  1 week

• Rates of fever

  Defined as temperature \>38C

  1 week

• Rates of abdominal pain

  Defined as pain described by the patient not caused by pancreatitis or perforation

  1 week

• Rates of death attributable to the procedure.

  As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503

  1 week

Secondary Outcomes (4)

• Technical Success

  1 day

• Treatment success

  2 weeks

• Procedural duration

  1 day

• Reintervention

  6 months

Study Arms (2)

EUS-BD

ACTIVE COMPARATOR

EUS-BD is a minimally invasive technique where the common bile duct (choledochoduodenostomy) is punctured under EUS-guidance and after transmural dilation, a stent is deployed for biliary drainage.

Procedure: EUS-BD

ERCP

ACTIVE COMPARATOR

At ERCP, the common bile duct will be selectively cannulated using a sphincterotome and guide wire technique. Once biliary access is obtained a stent will be deployed to facilitate biliary drainage.

Procedure: ERCP

Interventions

EUS-BD PROCEDURE

EUS-BD is a minimally invasive technique where the common bile duct (choledochoduodenostomy) is punctured under EUS-guidance and after transmural dilation, a stent is deployed for biliary drainage.

Also known as: Endoscopic Ultrasound-guided biliary drainage

EUS-BD

ERCP PROCEDURE

During the ERCP, a small catheter and guidewire is inserted into the bile duct and the stent can be deployed into the duct.

Also known as: Endoscopic Retrograde Cholangiopancreatography

ERCP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• Has jaundice due to malignant distal (more than 3cm distal to liver hilum) biliary obstruction.
• The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.

You may not qualify if:

• Age \<18 years
• Females who are pregnant or lactating. Pregnancy in females of childbearing potential will be determined by routine preoperative urine HCG testing.
• Coagulopathy which cannot be corrected (INR \>1.6, thrombocytopenia with platelet count \<50,000/ml)
• Has surgically altered gastrointestinal anatomy such as but not limited to (Billroth II/Roux en-Y, gastric bypass).
• Liver metastasis involving \>30% of liver volume.
• Liver cirrhosis with portal hypertension and/or ascites.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (20)

• Barkay O, Mosler P, Schmitt CM, Lehman GA, Frakes JT, Johanson JF, Qaseem T, Howell DA, Sherman S. Effect of endoscopic stenting of malignant bile duct obstruction on quality of life. J Clin Gastroenterol. 2013 Jul;47(6):526-31. doi: 10.1097/MCG.0b013e318272440e.

  PMID: 23269313 BACKGROUND

• Pereira-Lima JC, Jakobs R, Maier M, Kohler B, Benz C, Martin WR, Riemann JF. Endoscopic stenting in obstructive jaundice due to liver metastases: does it have a benefit for the patient? Hepatogastroenterology. 1996 Jul-Aug;43(10):944-8.

  PMID: 8884318 BACKGROUND

• Moss AC, Morris E, Mac Mathuna P. Palliative biliary stents for obstructing pancreatic carcinoma. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD004200. doi: 10.1002/14651858.CD004200.pub4.

  PMID: 16625598 BACKGROUND

• Coelho-Prabhu N, Shah ND, Van Houten H, Kamath PS, Baron TH. Endoscopic retrograde cholangiopancreatography: utilisation and outcomes in a 10-year population-based cohort. BMJ Open. 2013 May 31;3(5):e002689. doi: 10.1136/bmjopen-2013-002689.

  PMID: 23793659 BACKGROUND

• Lee JH, Krishna SG, Singh A, Ladha HS, Slack RS, Ramireddy S, Raju GS, Davila M, Ross WA. Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients. Gastrointest Endosc. 2013 Aug;78(2):312-24. doi: 10.1016/j.gie.2013.02.032. Epub 2013 Apr 13.

  PMID: 23591331 BACKGROUND

• Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.

  PMID: 17509029 BACKGROUND

• Williams EJ, Taylor S, Fairclough P, Hamlyn A, Logan RF, Martin D, Riley SA, Veitch P, Wilkinson ML, Williamson PR, Lombard M. Risk factors for complication following ERCP; results of a large-scale, prospective multicenter study. Endoscopy. 2007 Sep;39(9):793-801. doi: 10.1055/s-2007-966723.

  PMID: 17703388 BACKGROUND

• Holt BA, Hawes R, Hasan M, Canipe A, Tharian B, Navaneethan U, Varadarajulu S. Biliary drainage: role of EUS guidance. Gastrointest Endosc. 2016 Jan;83(1):160-5. doi: 10.1016/j.gie.2015.06.019. Epub 2015 Jul 26.

  PMID: 26215648 BACKGROUND

• Swan MP, Alexander S, Moss A, Williams SJ, Ruppin D, Hope R, Bourke MJ. Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation. Clin Gastroenterol Hepatol. 2013 Apr;11(4):430-436.e1. doi: 10.1016/j.cgh.2012.12.017. Epub 2013 Jan 11.

  PMID: 23313840 BACKGROUND

• Glomsaker T, Hoff G, Kvaloy JT, Soreide K, Aabakken L, Soreide JA; Norwegian Gastronet ERCP Group. Patterns and predictive factors of complications after endoscopic retrograde cholangiopancreatography. Br J Surg. 2013 Feb;100(3):373-80. doi: 10.1002/bjs.8992. Epub 2012 Dec 6.

  PMID: 23225493 BACKGROUND

• Kahaleh M, Tokar J, Mullick T, Bickston SJ, Yeaton P. Prospective evaluation of pancreatic sphincterotomy as a precut technique for biliary cannulation. Clin Gastroenterol Hepatol. 2004 Nov;2(11):971-7. doi: 10.1016/s1542-3565(04)00484-7.

  PMID: 15551249 BACKGROUND

• Crosara Teixeira M, Mak MP, Marques DF, Capareli F, Carnevale FC, Moreira AM, Ribeiro U Jr, Cecconello I, Hoff PM. Percutaneous transhepatic biliary drainage in patients with advanced solid malignancies: prognostic factors and clinical outcomes. J Gastrointest Cancer. 2013 Dec;44(4):398-403. doi: 10.1007/s12029-013-9509-3.

  PMID: 23760941 BACKGROUND

• Zhang GY, Li WT, Peng WJ, Li GD, He XH, Xu LC. Clinical outcomes and prediction of survival following percutaneous biliary drainage for malignant obstructive jaundice. Oncol Lett. 2014 Apr;7(4):1185-1190. doi: 10.3892/ol.2014.1860. Epub 2014 Feb 7.

  PMID: 24944690 BACKGROUND

• Lee E, Gwon DI, Ko GY, Sung KB, Yoon HK, Shin JH, Kim JH, Ko HK, Song HY. Percutaneous biliary covered stent insertion in patients with malignant duodenobiliary obstruction. Acta Radiol. 2015 Feb;56(2):166-73. doi: 10.1177/0284185114523267. Epub 2014 Feb 11.

  PMID: 24518689 BACKGROUND

• Shah JN, Marson F, Weilert F, Bhat YM, Nguyen-Tang T, Shaw RE, Binmoeller KF. Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla. Gastrointest Endosc. 2012 Jan;75(1):56-64. doi: 10.1016/j.gie.2011.08.032. Epub 2011 Oct 21.

  PMID: 22018554 BACKGROUND

• Artifon EL, Aparicio D, Paione JB, Lo SK, Bordini A, Rabello C, Otoch JP, Gupta K. Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage. J Clin Gastroenterol. 2012 Oct;46(9):768-74. doi: 10.1097/MCG.0b013e31825f264c.

  PMID: 22810111 BACKGROUND

• Dhir V, Itoi T, Khashab MA, Park DH, Yuen Bun Teoh A, Attam R, Messallam A, Varadarajulu S, Maydeo A. Multicenter comparative evaluation of endoscopic placement of expandable metal stents for malignant distal common bile duct obstruction by ERCP or EUS-guided approach. Gastrointest Endosc. 2015 Apr;81(4):913-23. doi: 10.1016/j.gie.2014.09.054. Epub 2014 Dec 5.

  PMID: 25484326 BACKGROUND

• Khashab MA, Valeshabad AK, Afghani E, Singh VK, Kumbhari V, Messallam A, Saxena P, El Zein M, Lennon AM, Canto MI, Kalloo AN. A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Dig Dis Sci. 2015 Feb;60(2):557-65. doi: 10.1007/s10620-014-3300-6. Epub 2014 Aug 1.

  PMID: 25081224 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 RESULT

• Bang JY, Navaneethan U, Hasan M, Hawes R, Varadarajulu S. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc. 2018 Jul;88(1):9-17. doi: 10.1016/j.gie.2018.03.012. Epub 2018 Mar 21.

  PMID: 29574126 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

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

• Shyam Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: February 16, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

US (1)