Cholangiocarcinoma, Pancreatic Cancer
Conditions
Keywords
Cholangiocarcinoma, Pancreatic Cancer, Radiofrequency, Ablation
Brief summary
The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.
Detailed description
Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. Blocked drainage causes abdominal pain, bloating, and nausea. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed. ERCP with stent placement is the standard medical procedure for people with bile duct and pancreatic cancer. The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents. The objectives are: • To assess assess the safety and effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Interventions
DEVICEEndoscopic bipolar radiofrequency probe (ENDOHPB)
EndoHPB (EMcision Ltd, UK) is a single use sterile device for use at ERCP or PTC. It is a 8F (2.6mm) catheter with a 1.8m working length, that is designed to be inserted into the target duct of the hepatic, biliary or pancreatic system over a guide wire. The device is compatible with endoscopes that have a working channel of 3.2mm or greater. It comprises of a coaxial over the wire (OTW) catheter with 2 ring electrodes spaced 8mm apart at its distal end. The distal electrode is 5mm from the leading edge of the catheter. The two electrodes at the distal end of EndoHPB are designed to produce a heating zone length of approximately 25 mm.
Sponsors
EMcision Limited
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Either gender greater than or equal to 18 years of age. * Pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced. * Biliary obstruction * Blocked self expanding mesh metal stent (SEMS) * Subjects capable of giving informed consent * Life expectancy of at least 3 months
Exclusion criteria
* Cardiac Pacemaker * Patient unstable for endoscopy * Inability to give informed consent * Uncorrected coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Bile Duct Stricture Diameter | 2 years | To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 2 years | To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Probe (ENDOHPB) Intervention: The EndoHPB Radiofrequency probe | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 16 |
| Overall Study | Study Termination | 7 |
Baseline characteristics
| Characteristic | Radiofrequency Probe (ENDOHPB) | — |
|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 12.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 Participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 16 / 29 |
Outcome results
Primary
Change From Baseline in Bile Duct Stricture Diameter
To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Time frame: 2 years
Population: Participants not analyzed has study was terminated before follow up data could be collected.
| Arm | Measure | Value |
|---|---|---|
| Radiofrequency Probe (ENDOHPB) | Change From Baseline in Bile Duct Stricture Diameter | 0 |
Secondary
Number of Participants With Adverse Events
To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Time frame: 2 years
Population: Preliminary analyses because study was terminated before follow up data could be collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Probe (ENDOHPB) | Number of Participants With Adverse Events | 16 participants |