EUS Biliary Drainage vs. ERCP

NCT03870386 | Completed DMC

• 1 other identifier: F11-36171
• Study Type: interventional
• Target: 144
• Locations: 2 countries
• Sites: 11

Brief Summary

Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.

Conditions

Biliary Obstruction

Keywords

EUS; ERCP; Lumen apposing metal stent; Biliary drainage; Biliary obstruction; Pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of re-intervention

  Obstruction and/or migration of stent

  1 year

Secondary Outcomes (4)

• Technical success

  1 year

• Clinical success

  1 year

• Stent patency

  1 year

• Early adverse events

  1 year

Study Arms (2)

EUS-BD with LAMS

EXPERIMENTAL

A curvilinear endoscope is inserted orally and advanced to the duodenal bulb. Biliary accessibility is confirmed via EUS and with Doppler to rule out any intervening vessels. For common bile ducts \< 15 mm in diameter, the biliary access is established via needle puncture with a 19-gauge needle followed by advancement of a 0.035 or 0.025 inch guidewire. A LAMS (AxiosTM) will then be inserted with cautery assistance without tract dilation and deployed. For common bile ducts \> 15 mm, the need for initial needle puncture and wire insertion is at the discretion of the endoscopist. A cholangiogram is then performed through the LAMS with contrast injection. The choice of stent size will be at the discretion of the endoscopist (8 x 8 mm or 6 x 8 mm).

Procedure: EUS-BD with LAMS

Traditional transpapillary metal stent via ERCP

ACTIVE COMPARATOR

A duodenoscope is advanced orally to the papilla. The bile duct is then cannulated with a sphincterotome using the guidewire-assisted technique. A cholangiogram is then performed followed by insertion of a self-expanding metal biliary stent. The performance of a biliary sphincterotomy prior to stent insertion and the choice of stent size (10x 40 mm, 10 x 60 mm, 10x 80 mm) will be at the discretion of the endoscopist.

Procedure: ERCP

Interventions

EUS-BD with LAMS PROCEDURE

Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy

EUS-BD with LAMS

ERCP PROCEDURE

Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.

Traditional transpapillary metal stent via ERCP

Eligibility Criteria

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

You may qualify if:

• Radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. Resectability based on tumor staging on axial imaging and surgeon evaluation.
• Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/L)
• Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
• Confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound
• Karnofsky index \> 30%
• ASA score \<IV
• Provision of informed consent

You may not qualify if:

• Hilar obstruction (biliary obstruction \< 2 cm from the hilum)
• Uncorrectable coagulopathy and/or thrombocytopenia
• Age \< 18
• Liver metastasis involving \> 30% of the liver volume
• Liver cirrhosis with portal hypertension or ascites
• Prior biliary sphincterotomy or stent placement
• Surgically altered anatomy
• Common bile duct measuring less than 1.2 cm will be excluded
• Patient with clinical and radiological evidence of gastric outlet obstruction

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (11)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, Bristish Columbia, Canada

Location

St-Paul Hospital

Vancouver, British Columbia, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

St-Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Centre Hospitalier Universite de Montreal

Montreal, Quebec, H2X3E4, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Hopital Charles Lemoynes

Montreal, Quebec, Canada

Location

Jewish General Hospital

Montreal, Canada

Location

Hôpital Privé des Peupliers

Paris, France

Location

Related Publications (28)

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• Chen YI, Sahai A, Donatelli G, Lam E, Forbes N, Mosko J, Paquin SC, Donnellan F, Chatterjee A, Telford J, Miller C, Desilets E, Sandha G, Kenshil S, Mohamed R, May G, Gan I, Barkun J, Calo N, Nawawi A, Friedman G, Cohen A, Maniere T, Chaudhury P, Metrakos P, Zogopoulos G, Bessissow A, Khalil JA, Baffis V, Waschke K, Parent J, Soulellis C, Khashab M, Kunda R, Geraci O, Martel M, Schwartzman K, Fiore JF Jr, Rahme E, Barkun A. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6.

  PMID: 37549753 DERIVED

• Chen YI, Callichurn K, Chatterjee A, Desilets E, Fergal D, Forbes N, Gan I, Kenshil S, Khashab MA, Kunda R, Lam E, May G, Mohamed R, Mosko J, Paquin SC, Sahai A, Sandha G, Teshima C, Barkun A, Barkun J, Bessissow A, Candido K, Martel M, Miller C, Waschke K, Zogopoulos G, Wong C; ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC). ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction. Trials. 2019 Dec 9;20(1):696. doi: 10.1186/s13063-019-3918-y.

  PMID: 31818329 DERIVED

MeSH Terms

Interventions

laminin beta2; Cholangiopancreatography, Endoscopic Retrograde

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

• Yen-I Chen, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 12, 2019
• Study Start: March 8, 2019
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10); FR (1)