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Completed

NCT Number: NCT05617872

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. KRAS mutation

    Time frame: 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 outcomes

  1. PLA2G1B concentration

    Time frame: The collected pancreatic juice will be tested in 6 months.

    PLA2G1B concentration of collected pancreatic juice of patients in different arms

  2. Immunoglobulin (Ig) concentration

    Time frame: The collected pancreatic juice will be tested in 6 months.

    Immunoglobulin (Ig) concentration of collected pancreatic juice of patients in different arms

  3. KRAS mutation load

    Time frame: The collected pancreatic juice will be tested in 6 months.

    KRAS mutation load detected of collected pancreatic juice of patients in different arms

  4. cfDNA concentration

    Time frame: The collected pancreatic juice will be tested in 6 months.

    cfDNA concentration of pancreatic juice

  5. DNA concentration of pancreatic juice

    Time frame: The collected pancreatic juice will be tested in 6 months.

    Genomic DNA concentration of exfoliated cells of pancreatic juice

  6. Weight

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2022
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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