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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline Group | Placebo Comparator | Inject 20ml normal saline solution into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes. |
|
| Vinegar 20ml Group | Experimental | 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. |
|
| Vinegar 40ml Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinegar 20ml | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| KRAS mutation | Consistency of KRAS mutation detection results in genomic DNA of pancreatic tissue and cell-free DNA in pancreatic juice | The collected pancreatic juice will be tested in 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| PLA2G1B concentration | PLA2G1B concentration of collected pancreatic juice of patients in different arms | The collected pancreatic juice will be tested in 6 months. |
| Immunoglobulin (Ig) concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xi Wu, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Saline (NaCl 0,9 %) (placebo) | Drug | Inject 20ml normal saline solution into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes. |
|
| Vinegar 40ml | Drug | 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. |
|
Immunoglobulin (Ig) concentration of collected pancreatic juice of patients in different arms
| The collected pancreatic juice will be tested in 6 months. |
| KRAS mutation load | KRAS mutation load detected of collected pancreatic juice of patients in different arms | The collected pancreatic juice will be tested in 6 months. |
| cfDNA concentration | cfDNA concentration of pancreatic juice | The collected pancreatic juice will be tested in 6 months. |
| DNA concentration of pancreatic juice | Genomic DNA concentration of exfoliated cells of pancreatic juice | The collected pancreatic juice will be tested in 6 months. |
| Weight | weight in grams of collected pancreatic juice of patients in different arms | The pancreatic juice will be weighed instantly 1 day (once) collected by EUS |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |