Pancreatic CancerNCT03054987
Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction
A study testing EUS-BD and ERCP in people with Pancreatic Cancer and Pancreatic Neoplasms, run by AdventHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Adenocarcinoma
- What is being tested?
- EUS-BD and ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, 32803
About this study
Official title: Randomized Trial Comparing Endoscopic Ultrasound-guided Biliary Drainage (EUS-BD) and Endoscopic Retrograde Cholangiopancreatography (ERCP) for Malignant Distal Biliary Obstruction
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.
Read the detailed description
The current curative treatment for patients with occlusion of the distal common bile duct by pancreatic cancer is pancreaticoduodenectomy (Whipple procedure). Unfortunately, more than 80% of patients have locally advanced or metastatic disease that requires neoadjuvant or palliative treatment. The goals of biliary drainage in the setting of locally advanced or metastatic pancreatic cancer are to palliate obstructive jaundice and lower serum bilirubin prior to systemic chemotherapy. In addition to resolving jaundice and associated pruritus, biliary drainage improves anorexia, indigestion and quality of life (1, 2). Endoscopic approach by means of retrograde cholangiopancreatography (ERCP) and biliary stent placement is the preferred treatment option for palliation of malignant obstructive jaundice. Endoscopic biliary drainage is safer than surgical bypass, with endoscopic placement of a plastic or metal stent having a lower relative risk of complications (3). When performed by experts, ERCP has favorable (80-90%) short-term (<90 days) success rates in the setting of malignant distal biliary obstruction (1-3). The rate of ERCP-associated adverse events (AEs) is 5-27% (4-7) and include pancreatitis, bleeding, infection, perforation and rarely death.
In a recent audit of 524 consecutive patients with an intact papilla who underwent ERCP at a tertiary endoscopy unit, 49 (9.4%) had a previously failed attempt at an outside facility and more than 80% of these failures were in the setting of a distal malignant stricture (8). Cancer in the pancreatic head or uncinate process can cause extensive ampullary inflammation that precludes successful biliary cannulation using standard techniques. In such circumstances, advanced techniques such as needle-knife sphincterotomy, dual wire technique, trans-papillary pancreatic sphincterotomy and cannulation over a pancreatic duct stent are performed to access the bile duct (9, 10). While the technical success rate for advanced techniques in expert hands is more than 85%, the procedure is associated with an AE rate of about 10-20% (9-11).
When ERCP is technically unsuccessful, patients are usually referred for interventional radiology-guided percutaneous transhepatic biliary drainage (PTBD). PTBD is usually a multi-step procedure that involves the initial placement of an external drainage catheter followed by internal trans-papillary stent placement. When the distal bile duct is severely strictured or when the intra-hepatic biliary system is non-dilated, PTBD is unsuccessful and is encountered in about 5-15% of patients with pancreatic cancer (12). The rate of short and long-term PTBD-related AEs is 5-10% and 20-30%, respectively (12-14). While most short-term AEs are due to infection and bleeding, the long-term AEs are due to stent dysfunction requiring frequent readmissions (12-14).
More recently, EUS-guided biliary drainage (EUS-BD) has emerged as a novel alternative to PTBD and ERCP for biliary decompression when advanced cannulation techniques fail. EUS-BD is a minimally invasive technique where the extra-hepatic common bile duct (choledochoduodenostomy) or intrahepatic bile duct (hepatogastrostomy) is punctured under EUS-guidance and after transmural dilation a stent is deployed for biliary drainage.
The potential advantages of EUS-BD are three-fold. Firstly, EUS-BD can be performed from multiple routes in the stomach and duodenum. Thus, duodenal stenosis is not a limitation to biliary access. Secondly, as biliary access is gained distant from the major duodenal papilla, the risk of post-procedure pancreatitis is low. Thirdly, as the deployed stent does not traverse the tumor, its patency could be longer. In a recent study of 95 patients with failed ERCP or inaccessible papilla, direct EUS-guided biliary drainage was successful in 86% of patients with an AE rate of 10.5% that included pancreatitis, bleeding, perforation, bile leak and infection (15). Most AEs were managed conservatively without the need for aggressive treatment measures. In another small, randomized trial of 25 patients with inoperable malignant biliary obstruction, there was no difference in clinical success, AEs, and costs between patients randomized to EUS-BD or PTBD (16). In a recent retrospective study of 208 patients with malignant obstructive jaundice treated by ERCP or EUS-BD directed biliary metal stent placement, there was no difference in the rates of technical success (>90% in both cohorts) or AEs (8.65% in both cohorts) between groups (17). However, patients who underwent ERCP had a 5% incidence of post-procedure pancreatitis compared to 0% in the EUS-BD cohort. Given these promising outcomes, EUS-BD is currently practiced as a complimentary therapy that allows biliary drainage when technical failure is encountered at ERCP. EUS-BD and PTBD have been shown to be comparable in effectiveness after failed ERCP, however patients who underwent PTBD had higher rates of adverse events and required additional interventions (19).
PTBD and EUS-BD have shown to be equally effective treatment options (16). The effectiveness of treatment outcomes between EUS-BD and ERCP needs to be evaluated. Since the treatment outcomes and safety profile of EUS-BD is comparable to ERCP and because EUS-BD is successful in more than 85% of patients with a failed ERCP, EUS-BD could be a first-line treatment option and not just a rescue measure for patients with malignant distal biliary obstruction.
- Being tested
- EUS-BD, ERCP
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-BDProcedure or surgery
Also called Endoscopic Ultrasound-guided biliary drainage
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.
ERCPProcedure or surgery
Also called Endoscopic Retrograde Cholangiopancreatography
During the ERCP, a small catheter and guidewire is inserted into the bile duct and the stent can be deployed into the duct.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of perforation
As defined by evidence of air or luminal contents outside the GI tract
Measured: 1 week
Rates of pancreatitis
Defined as typical pain with amylase/lipase >3 times normal
Measured: 1 week
Rates of bile leak
Not caused by pancreatitis or perforation
Measured: 1 week
Rates of bleeding
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Measured: 1 week
Rates of infection (cholangitis)
As defined by >38C >24 hours with cholestasis
Measured: 1 week
Rates of peritionitis
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Measured: 1 week
Rates of cholecystitis
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Measured: 1 week
Rates of pneumoperitoneum
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Measured: 1 week
Rates of fever
Defined as temperature >38C
Measured: 1 week
Rates of abdominal pain
Defined as pain described by the patient not caused by pancreatitis or perforation
Measured: 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
Measured: 1 week
Secondary outcomes (4)
Technical Success
Defined as successful placement of a stent for malignant distal biliary obstruction in the desired location as determined at ERCP and EUS in the index session.
Measured: 1 day
Treatment success
Clinical success is defined as decrease in direct bilirubin by 50% at 2 weeks
Measured: 2 weeks
Procedural duration
Defined as the time between procedure onset and completion of the procedure (stent deployment). The duration will be calculated in minutes from the time the echoendoscope or duodenoscope is positioned and the stent is deployed.
Measured: 1 day
Reintervention
Need for additional intervention (endoscopic, surgical or radiological) to relieve jaundice in the presence of dilated biliary system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startSep 2016
- Primary completionSep 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054987
- Sponsor's protocol ID
- 758636
- Status last verified
- Feb 2019
- First submitted
- 17 Jan 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be shared via publication and/or presentation.
Publications
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.
PubMed 23269313Pereira-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.
PubMed 8884318Moss 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.
PubMed 16625598Coelho-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.
PubMed 23793659Lee 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.
PubMed 23591331Andriulli 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.
PubMed 17509029Williams 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.
PubMed 17703388Holt 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.
PubMed 26215648Swan 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.
PubMed 23313840Glomsaker 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.
PubMed 23225493Kahaleh 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.
PubMed 15551249Crosara 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.
PubMed 23760941Zhang 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.
PubMed 24944690Lee 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.
PubMed 24518689Shah 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.
PubMed 22018554
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Endoscopic Ultrasound-guided Biliary Drainage (EUS-BD) and Endoscopic Retrograde Cholangiopancreatography (ERCP) for Malignant Distal Biliary Obstruction
- ClinicalTrials.gov ID
- NCT03054987
- Acronym / sponsor ID
- 758636
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current curative treatment for patients with occlusion of the distal common bile duct by pancreatic cancer is pancreaticoduodenectomy (Whipple procedure). Unfortunately, more than 80% of patients have locally advanced or metastatic disease that requires neoadjuvant or palliative treatment. The goals of biliary drainage in the setting of locally advanced or metastatic pancreatic cancer are to palliate obstructive jaundice and lower serum bilirubin prior to systemic chemotherapy. In addition to resolving jaundice and associated pruritus, biliary drainage improves anorexia, indigestion and quality of life (1, 2). Endoscopic approach by means of retrograde cholangiopancreatography (ERCP) and biliary stent placement is the preferred treatment option for palliation of malignant obstructive jaundice. Endoscopic biliary drainage is safer than surgical bypass, with endoscopic placement of a plastic or metal stent having a lower relative risk of complications (3). When performed by experts, ERCP has favorable (80-90%) short-term (<90 days) success rates in the setting of malignant distal biliary obstruction (1-3). The rate of ERCP-associated adverse events (AEs) is 5-27% (4-7) and include pancreatitis, bleeding, infection, perforation and rarely death.
In a recent audit of 524 consecutive patients with an intact papilla who underwent ERCP at a tertiary endoscopy unit, 49 (9.4%) had a previously failed attempt at an outside facility and more than 80% of these failures were in the setting of a distal malignant stricture (8). Cancer in the pancreatic head or uncinate process can cause extensive ampullary inflammation that precludes successful biliary cannulation using standard techniques. In such circumstances, advanced techniques such as needle-knife sphincterotomy, dual wire technique, trans-papillary pancreatic sphincterotomy and cannulation over a pancreatic duct stent are performed to access the bile duct (9, 10). While the technical success rate for advanced techniques in expert hands is more than 85%, the procedure is associated with an AE rate of about 10-20% (9-11).
When ERCP is technically unsuccessful, patients are usually referred for interventional radiology-guided percutaneous transhepatic biliary drainage (PTBD). PTBD is usually a multi-step procedure that involves the initial placement of an external drainage catheter followed by internal trans-papillary stent placement. When the distal bile duct is severely strictured or when the intra-hepatic biliary system is non-dilated, PTBD is unsuccessful and is encountered in about 5-15% of patients with pancreatic cancer (12). The rate of short and long-term PTBD-related AEs is 5-10% and 20-30%, respectively (12-14). While most short-term AEs are due to infection and bleeding, the long-term AEs are due to stent dysfunction requiring frequent readmissions (12-14).
More recently, EUS-guided biliary drainage (EUS-BD) has emerged as a novel alternative to PTBD and ERCP for biliary decompression when advanced cannulation techniques fail. EUS-BD is a minimally invasive technique where the extra-hepatic common bile duct (choledochoduodenostomy) or intrahepatic bile duct (hepatogastrostomy) is punctured under EUS-guidance and after transmural dilation a stent is deployed for biliary drainage.
The potential advantages of EUS-BD are three-fold. Firstly, EUS-BD can be performed from multiple routes in the stomach and duodenum. Thus, duodenal stenosis is not a limitation to biliary access. Secondly, as biliary access is gained distant from the major duodenal papilla, the risk of post-procedure pancreatitis is low. Thirdly, as the deployed stent does not traverse the tumor, its patency could be longer. In a recent study of 95 patients with failed ERCP or inaccessible papilla, direct EUS-guided biliary drainage was successful in 86% of patients with an AE rate of 10.5% that included pancreatitis, bleeding, perforation, bile leak and infection (15). Most AEs were managed conservatively without the need for aggressive treatment measures. In another small, randomized trial of 25 patients with inoperable malignant biliary obstruction, there was no difference in clinical success, AEs, and costs between patients randomized to EUS-BD or PTBD (16). In a recent retrospective study of 208 patients with malignant obstructive jaundice treated by ERCP or EUS-BD directed biliary metal stent placement, there was no difference in the rates of technical success (>90% in both cohorts) or AEs (8.65% in both cohorts) between groups (17). However, patients who underwent ERCP had a 5% incidence of post-procedure pancreatitis compared to 0% in the EUS-BD cohort. Given these promising outcomes, EUS-BD is currently practiced as a complimentary therapy that allows biliary drainage when technical failure is encountered at ERCP. EUS-BD and PTBD have been shown to be comparable in effectiveness after failed ERCP, however patients who underwent PTBD had higher rates of adverse events and required additional interventions (19).
PTBD and EUS-BD have shown to be equally effective treatment options (16). The effectiveness of treatment outcomes between EUS-BD and ERCP needs to be evaluated. Since the treatment outcomes and safety profile of EUS-BD is comparable to ERCP and because EUS-BD is successful in more than 85% of patients with a failed ERCP, EUS-BD could be a first-line treatment option and not just a rescue measure for patients with malignant distal biliary obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-BD | Active comparator | Procedure: EUS-BDEUS-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. |
| ERCP | Active comparator | Procedure: ERCPAt 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-BDAlso: Endoscopic Ultrasound-guided biliary drainageEUS-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 or surgery | EUS-BD |
| ERCPAlso: Endoscopic Retrograde CholangiopancreatographyDuring the ERCP, a small catheter and guidewire is inserted into the bile duct and the stent can be deployed into the duct. | Procedure or surgery | ERCP |
Primary outcome
Rates of perforation
Time frame: 1 week
As defined by evidence of air or luminal contents outside the GI tract
Rates of pancreatitis
Time frame: 1 week
Defined as typical pain with amylase/lipase >3 times normal
Rates of bile leak
Time frame: 1 week
Not caused by pancreatitis or perforation
Rates of bleeding
Time frame: 1 week
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Rates of infection (cholangitis)
Time frame: 1 week
As defined by >38C >24 hours with cholestasis
Rates of peritionitis
Time frame: 1 week
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Rates of cholecystitis
Time frame: 1 week
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Rates of pneumoperitoneum
Time frame: 1 week
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
Rates of fever
Time frame: 1 week
Defined as temperature >38C
Rates of abdominal pain
Time frame: 1 week
Defined as pain described by the patient not caused by pancreatitis or perforation
Rates of death attributable to the procedure.
Time frame: 1 week
As defined by "A lexicon for endoscopic adverse events: report of an ASGE workshop" PMID: 20189503
4 secondary outcomes
Technical Success
Time frame: 1 day
Treatment success
Time frame: 2 weeks
Procedural duration
Time frame: 1 day
Reintervention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 23269313Barkay 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.
- Background: PubMed 8884318Pereira-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.
- Background: PubMed 16625598Moss 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.
- Background: PubMed 23793659Coelho-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.
- Background: PubMed 23591331Lee 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.
- Background: PubMed 17509029Andriulli 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.
- Background: PubMed 17703388Williams 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.
- Background: PubMed 26215648Holt 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.
- Background: PubMed 23313840Swan 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.
- Background: PubMed 23225493Glomsaker 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.
- Background: PubMed 15551249Kahaleh 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.
- Background: PubMed 23760941Crosara 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.
- Individual participant dataSharing planned: Yes. The data will be shared via publication and/or presentation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyam Varadarajulu, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-BD and ERCP in people with Pancreatic Cancer and Pancreatic Neoplasms, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of perforation (time frame: 1 week). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054987, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.