ERCP guided stent insertion for malignant biliary obstruction

ERCP-guided stent insertion

EUS-guided stent insertion for malignant biliary obstruction

EUS guided stent insertion

Kwanghyuck Lee, MD, phD

1. Purpose of the study

   -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction
2. Subjects of the study

   -Patients who have biliary obstruction owing to malignant tumors
3. Methods of the study

   * Prospective randomized controlled study
   * Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
   * Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
   * After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.

1. Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin \>= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
2. Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT \> 1.5 INR, PLT \< 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction

Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction

Samsung Medical Center

Professor of Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine

Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intraductal radiofrequency ablation of tumor prior to stent placement

Endobiliary radiofrequency ablation (eRFA)

Intraductal placement of uncovered metal stent

uncovered self-expanding metal stent (uSEMS)

Jeska Fritzsche

Jeska Fritzsche, MD

A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial

Defined as period between initial procedure and recurrence of biliary obstruction. Recurrence of biliary obstruction is defined as recurrent jaundice (conjugated bilirubin ≥ 40 umol/l (≥2.3 mg/dl)), presence of biochemical evidence of cholestasis along with dilatation of the drained bile duct(s), or endoscopic findings suggesting stent occlusion.

EORTC QLQ-C30, BIL21 and EQ-5D questionnaires are to be filled out 4 weeks and every3 months after the intervention

Defined as completion of ablation of the malignant stenosis through which the stent will be placed using RFA for 120 seconds with 7W.

In case of inadequate drainage prior to the procedure (bilirubin ≥40 umol/L \[≥2.3 mg/dl\]), defined as 50% decrease or normalization of bilirubin level within 14 days of the procedure or relieve of symptoms in case of cholangitis. In case of sufficient drainage prior to the procedure, a persistent bilirubin level \<40 umol/L (\<2.3 mg/dl) after 14 days is considered functional success.

1. Stent occlusion due to tumour ingrowth
2. Stent occlusion due to tumour overgrowth
3. Stent occlusion due to sludge with/or without stones, hemobilia, food impaction
4. Stent migration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction	NCT01421836	Tumor Appearanc...	ERCP-guided ste... EUS guided sten...	18 Years -	Samsung Medical Center
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma	NCT05546372	Perihilar Chola...	Endobiliary rad... uncovered self-...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction	NCT01421836	Tumor Appearanc...	ERCP-guided ste... EUS guided sten...	18 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for stent patency