Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

Study Overview
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Brief Summary
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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: 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
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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.

Official Title
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Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Vinegar 20ml
* Drug: Saline
* Drug: Vinegar 40ml
* Drug: Vinegar 20ml, 3 phases


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br>20ml saline infused into duodenum and suction for 5 minutes via EUS | Drug: Saline<br>* 20ml saline infused into duodenum and suction for 5 minutes via EUS<br>|
| Experimental: Vinegar 20ml<br>20ml vinegar infused into duodenum and suction for 5 minutes via EUS | Drug: Vinegar 20ml<br>* 20ml vinegar infused into duodenum and suction for 5 minutes via EUS<br>|
| Active Comparator: Vinegar 40ml<br>40ml vinegar infused into duodenum and suction for 5 minutes via EUS | Drug: Vinegar 40ml<br>* 40ml vinegar infused into duodenum and suction for 5 minutes via EUS<br>|
| Active Comparator: Vinegar 20ml, 0-5min<br>20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the first 5 minutes | Drug: Vinegar 20ml, 3 phases<br>* 20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the first 5 minutes, 5-10 minutes, and 10-15 minutes, separately.<br>|
| Active Comparator: Vinegar 20ml, 5-10min<br>20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the 5-10 minutes | Drug: Vinegar 20ml, 3 phases<br>* 20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the first 5 minutes, 5-10 minutes, and 10-15 minutes, separately.<br>|
| Active Comparator: Vinegar 20ml, 10-15min<br>20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the 10-15 minutes | Drug: Vinegar 20ml, 3 phases<br>* 20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the first 5 minutes, 5-10 minutes, and 10-15 minutes, separately.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cfDNA concentration | cfDNA concentration of collected pancreatic juice of patients in different arms | The collected pancreatic juice will be tested in 6 months. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, Endoscopic ultrasound, pancreatic juice