Clinical Research Directory

A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.

Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)

Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow. There are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection. Currently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking. The purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.

Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial

The purpose of this study is to compare the efficacy and safety between EUS-HGAS and EUS-HGS. We hypothesized that EUS-HGAS provides lower recurrent biliary obstruction (RBO) rate but with a comparable safety profile to EUS-HGS.

Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction

Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Conventionally, the stent is placed across the papilla, the opening between the bile duct and the intestine, with one end inside the intestine. An alternative method places the stent entirely inside the bile duct, above the papilla, which may reduce bacterial contamination from the intestine and help the stent stay open longer. However, previous studies have shown inconsistent results. This multicenter randomized trial will compare these two stent placement methods in patients with unresectable malignant hilar biliary obstruction. About 70 participants will be randomly assigned (50:50) to receive either a suprapapillary (above the papilla) or a transpapillary (across the papilla) plastic stent during the same standard endoscopic procedure (ERCP). Both stents are approved, commonly used medical devices. The main question is which method keeps the bile duct open longer before re-blockage. Participants will be followed with regular clinic visits, and safety will be monitored throughout the study.

12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction

Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. This prospective, randomized clinical trial will compare these two stent types in adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) and are scheduled for metallic stent placement through the existing PTBD tract. A total of 60 participants will be enrolled. After stent placement, participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The study will evaluate recurrent biliary obstruction, stent patency duration, reintervention, overall survival, and procedure-related complications. The results are expected to provide evidence for selecting the most appropriate 12-mm metallic stent for patients with unresectable malignant distal biliary obstruction.

Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction

This study is a multicenter, randomized clinical trial designed to compare the effectiveness and safety of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) with a conventional plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction. In patients who require biliary drainage before surgery, stent placement is commonly performed using endoscopic retrograde cholangiopancreatography (ERCP). However, the optimal stent type remains uncertain. Participants will be randomly assigned to receive either the modified FCSEMS or a plastic stent. The primary objective is to evaluate the rate of stent-related complications requiring reintervention before surgery. Secondary outcomes include stent patency, adverse events, and surgical outcomes. The results of this study are expected to help determine the most appropriate stent strategy for patients undergoing surgery for pancreatic cancer.

EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.

EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety. The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.

Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent

This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain. A common procedure called ERCP sometimes doesn't work in these patients. A newer method called EUS-guided choledochoduodenostomy (EUS-CDS) uses internal ultrasound to place a special metal tube (called a LAMS) to allow bile to drain. However, over time this stent can still become blocked. To reduce this risk, doctors can place a second stent inside the first. This study is comparing two types of these second stents: * A plastic stent (double pigtail stent or DPS) * A metal stent (fully covered self-expanding metal stent or FCSEMS) The study will include patients at Waikato Hospital. After the first stent is placed, they will be randomly assigned to receive either a DPS or FCSEMS. Patients will be followed for 6 months to see how well the stents work. The aim is to find out which approach keeps the bile duct open longer and reduces the need for further procedures or hospitalisation, helping improve care and comfort for people with advanced cancer

PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial

Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving success during therapeutic ERCP is selective biliary cannulation (SBC). Nevertheless, SBC doesn't consistently yield favorable outcomes, even among expert endoscopists, failing in around 25% to 50% of cases with standard ERCP approach (sphincterotome and guidewire). In such situations, depending on the endoscopist's experience and preference, various advanced techniques come into play. These encompass the double guidewire cannulation approach, needle-knife precut papillotomy or fistulotomy, and transpancreatic sphincterotomy, serving as potential rescue methods. In recent times, the EUS-guided approach has been gaining increasing significance. Initially, it was viewed as a rescue option in cases where advanced ERCP techniques failed (5-15% of cases). More recently, it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction.

EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.