Clinical trial NCT03530527: Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture
Official title: Endoscopic Retrograde Cholangiopancreatography Versus Endoscopic Ultrasound Guided Biliary Drainage in Inoperable Malignant Distal Bile Duct Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Biliary Stricture
Keywords: ERCP
Endoscopic ultrasound (EUS) guided biliary drainage
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these patients. However, ERCP is sometime unsuccessful to perform because of the presence of the high grade biliary stricture, tumor invasion of duodenum and ampulla of vater and surgically altered gastrointestinal anatomy. Endoscopic ultrasound (EUS) guided biliary drainage has been emerged as an alternative procedure to traditional surgical bypass and percutaneous trans hepatic biliary drainage after failed ERCP. There were few data to directly compare between ERCP and EUS guided biliary drainage and in patients with malignant high grade biliary stricture.

Detailed description: The aim of this study is comparing the efficacy and complications between ERCP and EUS guided biliary drainage in patients with malignant high grade biliary stricture. Malignant high grade biliary stricture has not been well defined. The investigators define this malignant high grade biliary stricture using these arbitrary number include total bilirubin ≥ 15 mg/dl and or bile duct diameter ≥12 mm. based on the investigation's experience.

The study will be divided patients with inoperable malignant high grade biliary stricture into 2 groups, group (A) will be undergone ERCP with biliary stenting and group (B) will be undergone EUS guided biliary drainage. If the assigned intervention is not successful, then patients will be crossed-over to the another intervention.

Eligibility criteria: Inclusion Criteria: I) Patients aged \> 18 years. II) Clinical, laboratory data, imaging and or histology suggestive of malignant distal bile duct strictures that occurs as a result of pancreatic adenocarcinoma, cholangiocarcinoma, ampullary carcinoma, duodenal carcinoma, gallbladder cancer and metastasis malignant bile duct obstruction III) Inoperability by tumor staging, medically unfit or patient wishes

1. distant metastasis
2. major vascular involvement (unreconstructible Superior mesenteric vein/Portal vein, superior mesenteric artery, common hepatic artery and celiac artery)
3. metastasis to lymphnode beyond the field or surgery IV) Jaundice, total bilirubin ≥15 mg/dl and/ or Common bile duct diameter ≥12 mm

Exclusion Criteria: I) pregnancy II) uncorrectable coagulopathy ( international normalized ratio ≥ 1.5 ) III) thrombocytopenia (platelet count \< 50,000 ) IV) extremely poor general condition, ERCP with stent insertion impossible for ethical reasons V) an extension of stricture to the main biliary confluent (hilum) or the existence of obstructive duodenal invasion VI) active suppurative cholangitis VI) surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction ) VII ) previous treatment with bile duct stent.

Primary outcomes:
measure: Technical success rate
timeFrame: 24 hours
Secondary outcomes:
measure: Clinical success rates
timeFrame: 2 weeks
measure: Total procedure time
timeFrame: 24 hours
measure: The complication rates
timeFrame: 4 weeks
measure: The mortality rates
timeFrame: 1 weeks
measure: Stent patency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
city: Hat Yai
country: Thailand
facility: NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkla
Study officials:
affiliation: NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
name: Nisa Netinatsunton, MD.
role: PRINCIPAL_INVESTIGATOR
References: