Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Saline; Drug: Vinegar 20ml; Drug: Vinegar 40ml; Drug: Vinegar 20ml, 3 phases

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen Shi, M.D.; Phone Number: +8613699256758; Email: ysfn_2005@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Xi Wu, M.D.; Phone Number: +8613683296860; Email: wxpumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Xi Wu, M.D., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pancreatic cancer; Endoscopic ultrasound; pancreatic juice
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Anti-Infective Agents; Anti-Bacterial Agents; Acetic Acid
• Other Study ID Numbers: K2379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No