Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Biliary Tract Neoplasms

Jaundice

Cholestasis

Jaundice, Obstructive

Hyperbilirubinemia

Skin Manifestations

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

ComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)

uncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)

ComVi stent

Uncovered SEMS

Ji Kon Ryu, MD, PhD

Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a limited number of reports on the management of occluded SEMS with various results. The aim of this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent ERBD after the occlusion of initial SEMSs.

Endoscopic placement of self-expandable metallic stents (SEMSs) is the mainstay of palliative measures for alleviating obstructive jaundice secondary to advanced cholangiocarcinoma. Previous meta-analysis showed no significant difference in stent patency between covered and uncovered SEMS, which are currently available. However, information on secondary SEMS insertion is still scarce, and there has been no prospective trial comparing efficacy of secondary stenting between covered and uncovered SEMS for the management of occluded metal stent in malignant biliary obstruction. Previously, only two small retrospective studies addressed this issue. Given the absence of prospective trial on re-intervention for occluded SEMS in malignant biliary obstruction, we aimed to prospectively compare the efficacies and complication rates of secondary ComVi stent (cSEMS) and uSEMS for the management of such condition.

Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Re-intervention for Occluded Biliary Metal Stent in Malignant Distal Bile Duct Obstruction: a Prospective Randomized Multi-center Trial Comparing Covered and Uncovered Metal Stent

period between stent insertion and stent occlusion or death of the patient

Technical success was achieved when the SEMS was placed across the stricture with appropriate radiographic positioning and immediate biliary decompression

Clinical success was achieved in the case of ≥ 50% reduction or normalization of total bilirubin level (≤ 1.2 mg/dL)

stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

Seoul National University Hospital

Professor

Endoscopic Ultrasound-guided Biliary Drainage

Endoscopic Retrograde Cholangiopancreatography

We observe the bile duct through endoscopic ultrasound, then puncture through the gastric or duodenum wall and place a guide wire, expanding along the guide wire, finally place a stent between the bile duct and the stomach or intestine for drainage.

EUS-BD

We use a Duodenoscopy to pass through mouth down to the small opening where the bile duct and pancreatic drain. A small narrow catheter is passed through the scope to gain access to the drainage duct , followed by advancement of a wire deep into the duct. A small cut is made at the bile duct opening to help facilitate a stent placed in the bile duct.

ERCP-BD

Xi WU, M.D.

Xi WU

The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.

A RCT of Low MBO Drainage Strategies

A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies

The interval between the operation day and the occurrence of cholangitis and biliary obstruction

Peking Union Medical College Hospital

associate professor，M.D.

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

All patients with perihilar malignant biliary obstruction treated with endoscopic drainage. This drainage can be multimodal using endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS)-guided biliary drainage.

All patients with perihilar malignant biliary obstruction treated with percutaneous drainage

Endoscopic drainage

Percutaneous transhepatic biliary drainage

This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction.

Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.

Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

Comparison of Efficacy and Safety of Endoscopic Biliary Drainage and Percutaneous Transhepatic Biliary Drainage for the Management of Perihilar Malignant Biliary Obstruction: a Monocentric Retrospective Study

Diminution of 20% of more on day 7 of the bilirubin serum level

total number of procedures, including all endoscopic and radiological interventions

total number of unplanned hospital admissions (for unplanned biliary drainage, cholangitis or other complications...)

Central Hospital, Nancy, France

Percutaneous Transhepatic Biliary Drainage

Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

PTBD group

Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

ENBD group

Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

EBS group

Houbao Liu, PHD

The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).

Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice

Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice of Extrahepatic Bile Duct: A Multi-center, Prospective, Open-labeled, Real World Study Based on Electronic Data Capture System

Complication rate between PBD (preoperative biliary drainage) and radical surgery

Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)

Mortality between PBD and 4 weeks after surgery

Shanghai Zhongshan Hospital

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Biliary Tract Cancer

6 mm Nitinol Zilver Stent

10 mm Nitinol Zilver Stent

10 mm Stainless Steel Wallstent

Douglas Howell, M.D.

This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.

This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.

Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction

Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\>= 6 months after placement).

Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.

Cook Group Incorporated

No adverse events were captured due to terminal patients.

6 mm Zilver

10 mm Zilver

10 mm Wallstent

Total

Age Continuous

Sex: Female, Male

Patients with Biliary Sphincterotomy

Patients without Biliary Sphincterotomy

Biliary Sphincterotomy

Patients with Previous Plastic Stent

Patients without Previous Plastic Stent

Previous Plastic Stent

Patients with Pancreatic Cancer

Patients with Metastatic Cancer

Patients with Cholangiocarcinoma

Patients with Gallbladder Cancer

Patients with Other Cancer

Patients without Tumor

Tumor Diagnosis

Bilirubin

The Karnofsky index runs from 100 to 0, where 100 is "perfect" health and 0 is death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents	NCT01315522	Biliary Tract N... Jaundice, Obstr...	ComVi stent Uncovered SEMS	20 Years -	Seoul National University Hospital
A RCT of Low MBO Drainage Strategies	NCT06196164	Jaundice, Obstr... Cholangiopancre... Endoscopic Ultr...	EUS-BD ERCP-BD	18 Years -	Peking Union Medical College Hospital
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents	NCT01315522	Biliary Tract N... Jaundice, Obstr...	ComVi stent Uncovered SEMS	20 Years -	Seoul National University Hospital
Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction	NCT05078801	Perihilar Chola... Jaundice, Obstr...	Endoscopic drai... Percutaneous tr...	18 Years -	Central Hospital, Nancy, France
A RCT of Low MBO Drainage Strategies	NCT06196164	Jaundice, Obstr... Cholangiopancre... Endoscopic Ultr...	EUS-BD ERCP-BD	18 Years -	Peking Union Medical College Hospital
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents	NCT01315522	Biliary Tract N... Jaundice, Obstr...	ComVi stent Uncovered SEMS	20 Years -	Seoul National University Hospital
Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction	NCT05078801	Perihilar Chola... Jaundice, Obstr...	Endoscopic drai... Percutaneous tr...	18 Years -	Central Hospital, Nancy, France
Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice	NCT03527875	Jaundice, Obstr... Klatskin Tumor	PTBD group ENBD group EBS group	18 Years - 80 Years	Shanghai Zhongshan Hospital
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)	NCT00196105	Biliary Tract N... Pancreatic Neop... Jaundice, Obstr...	6 mm Nitinol Zi... 10 mm Nitinol Z... 10 mm Stainless...	21 Years -	Cook Group Incorporated
Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction	NCT05078801	Perihilar Chola... Jaundice, Obstr...	Endoscopic drai... Percutaneous tr...	18 Years -	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for jaundice, obstructive