Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, Endoscopic ultrasound, pancreatic juice
Brief summary
The goal of this clinical trial is to learn about the feasibility of collecting pancreatic juice through duodenal aspiration by ultrasound endoscopy (EUS) for molecular marker testing after intraduodenal infusion of vinegar in patients with suspected pancreatic cancer and who are scheduled to have endoscopic ultrasound with fine needle aspiration (EUS-FNA). The main questions it aims to answer are: * Is vinegar-induced collection of duodenal pancreatic juice via endoscopic ultrasound feasible? * What is the best operating condition (amount of vinegar, collection time, etc.) of vinegar-induced collection of duodenal pancreatic juice via endoscopic ultrasound? Participants will have EUS as scheduled, during which different amount of vinegar will be infused into duodenum and then pancreatic juice be collected for different time via suction by EUS. Researchers will compare the amount of collected pancreatic juice and molecular marker level in different groups to determine the best operating condition for vinegar-induced collection of duodenal pancreatic juice via endoscopic ultrasound.
Detailed description
This is a single center, prospective, randomized-controlled study. Participants who are diagnosed as suspected pancreatic cancer and are schedule to have EUS-FNA will have saline or different amount of vinegar infused into duodenum and pancreatic juiced collected via EUS suction during different period of time under intravenous anesthesia. The collected pancreatic juice will be weighed instantly and frozen in 10 minutes under -80℃ for further tests. Researchers will compare the weight, cfDNA (cell free DNA) concentration, PLA2G1B (Phosphatidylcholine 2-acylhydrolase 1B) concentration, immunoglobulin concentration and KRAS (Kirsten rat sarcoma viral oncogene) mutation load of collected pancreatic juice from different arms.
Interventions
DRUGVinegar 20ml
Inject 20ml vinegar (5% acetic acid solution) into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes.
DRUGSaline (NaCl 0,9 %) (placebo)
Inject 20ml normal saline solution into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes.
DRUGVinegar 40ml
Inject 40ml vinegar (5% acetic acid solution) into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: 18 years old or older * Diagnosis: CT, MRI, transabdominal ultrasound or other imaging examinations showed a pancreatic mass, and 3 endoscopists agreed on the diagnosis of suspected pancreatic cancer * EUS-FNA is required to perform further treatment strategy * The patient can understand the study protocol, is willing to participate in the study and can provide written informed consent
Exclusion criteria
* The patient's clinical and imaging features do not support the diagnosis of suspected pancreatic cancer, judged by 3 endoscopists * The patient refuses to have EUS-FNA * The patient is unsuitable for EUS-FNA because of his/her general condition, or contraindicated for anesthesia * The patient's imaging suggests severe pancreatic duct obstruction * The patient cannot understand the conditions and objectives of this study, or refuse to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KRAS mutation | The collected pancreatic juice will be tested in 6 months. | Consistency of KRAS mutation detection results in genomic DNA of pancreatic tissue and cell-free DNA in pancreatic juice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PLA2G1B concentration | The collected pancreatic juice will be tested in 6 months. | PLA2G1B concentration of collected pancreatic juice of patients in different arms |
| Immunoglobulin (Ig) concentration | The collected pancreatic juice will be tested in 6 months. | Immunoglobulin (Ig) concentration of collected pancreatic juice of patients in different arms |
| KRAS mutation load | The collected pancreatic juice will be tested in 6 months. | KRAS mutation load detected of collected pancreatic juice of patients in different arms |
| cfDNA concentration | The collected pancreatic juice will be tested in 6 months. | cfDNA concentration of pancreatic juice |
| DNA concentration of pancreatic juice | The collected pancreatic juice will be tested in 6 months. | Genomic DNA concentration of exfoliated cells of pancreatic juice |
| Weight | The pancreatic juice will be weighed instantly 1 day (once) collected by EUS | weight in grams of collected pancreatic juice of patients in different arms |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXi Wu, M.D.
Peking Union Medical College Hospital
Outcome results
None listed