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Pancreatic CancerNCT05617872

Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

A study testing Vinegar 20ml and Vinegar 40ml in people with Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Vinegar 20ml and Vinegar 40ml
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteChina
Study dates
30 Dec 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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?
Read more

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.

Read the 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.

Being tested
Vinegar 20ml, Saline (NaCl 0,9 %) (placebo), Vinegar 40ml
Keywords
pancreatic cancer, Endoscopic ultrasound, pancreatic juice
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vinegar 20mlDrug

    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 40mlDrug

    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.

Study groups in NCT05617872
Study groupRoleWhat they receive
Normal Saline GroupPlacebo comparatorInject 20ml normal saline solution into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes.
Receives: Drug: Saline (NaCl 0,9 %) (placebo)
Vinegar 20ml GroupExperimentalInject 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.
Receives: Drug: Vinegar 20ml
Vinegar 40ml GroupActive comparatorInject 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.
Receives: Drug: Vinegar 40ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KRAS mutation

    Consistency of KRAS mutation detection results in genomic DNA of pancreatic tissue and cell-free DNA in pancreatic juice

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

Secondary outcomes (6)

  1. PLA2G1B concentration

    PLA2G1B concentration of collected pancreatic juice of patients in different arms

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

  2. Immunoglobulin (Ig) concentration

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

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

  3. KRAS mutation load

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

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

  4. cfDNA concentration

    cfDNA concentration of pancreatic juice

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

  5. DNA concentration of pancreatic juice

    Genomic DNA concentration of exfoliated cells of pancreatic juice

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

  6. Weight

    weight in grams of collected pancreatic juice of patients in different arms

    Measured: The pancreatic juice will be weighed instantly 1 day (once) collected by EUS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start30 Dec 2022
  3. Primary completion1 May 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05617872
Sponsor's protocol ID
K2379
Status last verified
Mar 2026
First submitted
6 Nov 2022
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vinegar 20ml and Vinegar 40ml in people with Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KRAS mutation (time frame: The collected pancreatic juice will be tested in 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05617872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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