ABC-02 regime - gemcitabine and cisplatin with a shortened hydration time and administration of a newer antiemetic

ABC-02 regime - gemcitabine and cisplatin with currently approved hydration time and administration of the current choice of antiemetic

Gallbladder Cancer

Hydration is reduced to 1 hour and 40 minutes and Akynzeo is administered as an oral drug instead of Ondansetron being given as an IV before chemotherapy.

Shortened hydration time and dispensary of Akynzeo

Hydration remains at around 6 hours and 30 minutes due to no oral fluids being consumed prior to treatment and normal saline being administered for 90 minutes before cisplatin and then for 2 hours after cisplatin and before gemcitabine administration

Standard of care

Imperial College Healthcare NHS Trust

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

A Prospective Study of Tolerance Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

To compare the proportion of patients who experience CTCAE V3.0 grade 3 or 4 nausea (using a shortened hydration protocol and a modern antiemetic regimen) with those who are in the ABC02 trial arm which used a longer hydration procedure and a standard antiemetic regimen

To compare proportion of patients who experience CTCAE V3.0 grade 3 or 4 impaired renal function

To compare proportion of patients who have a complete response i.e. no nausea and vomiting recorded as a toxicity

To compare the proportion of patients who experience renal dysfunction (a deterioration of calculated GFR of below 60)

To determine the incidence of early and delayed chemotherapy induced emesis using the MAT antiemesis tool

To determine the incidence of nocturia in the first night after chemotherapy

Measuring the length of hospital visit (time in to time out) for each patient per treatment visit and comparing the difference between arms

Chugai Pharma UK Limited

Intervention:
The EndoHPB is an endoscopic bipolar catheter designed to ablate tissue in malignant tumors within luminal structures, such as the biliary tree or pancreatic ducts. EndoHPB can be deployed via an ERCP or Percutaneous Transhepatic Cholangiographic (PTC) route. 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

Intervention: The EndoHPB Radiofrequency probe

Radiofrequency Probe (ENDOHPB)

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Intervention:
The EndoHPB Radiofrequency probe

Change From Baseline in Bile Duct Stricture Diameter

To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Number of Participants With Adverse Events

Overall Study

Michel Kahaleh

Cholangiocarcinoma

Pancreatic Cancer

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.

Endoscopic bipolar radiofrequency probe (ENDOHPB)

Weill Medical College of Cornell University

Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Chief, Advanced Endoscopy

EMcision Limited

Patients scheduled for percutaneous drainage

Patients scheduled for a surgical bypass or resection of a high bile duct tumor.

Liver Cancer

Bile Duct Cancer

complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.

questionnaires

complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks.

cholangiocarcinoma/pahoinvointi

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Quality Of Life in Patients With Malignant Biliary Obstruction

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