Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

NCT05617872 | Completed

• 1 other identifier: K2379
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; Endoscopic ultrasound; pancreatic juice

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• PLA2G1B concentration

  The collected pancreatic juice will be tested in 6 months.

• Immunoglobulin (Ig) concentration

  The collected pancreatic juice will be tested in 6 months.

• KRAS mutation load

  The collected pancreatic juice will be tested in 6 months.

• cfDNA concentration

  The collected pancreatic juice will be tested in 6 months.

• DNA concentration of pancreatic juice

  The collected pancreatic juice will be tested in 6 months.

Study Arms (3)

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.

Drug: Saline (NaCl 0,9 %) (placebo)

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.

Drug: Vinegar 20ml

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.

Drug: Vinegar 40ml

Interventions

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.

Vinegar 20ml Group

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.

Normal Saline Group

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.

Vinegar 40ml Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Acetic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Xi Wu, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, M.D.

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 16, 2022
• Study Start: December 30, 2022
• Primary Completion: May 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)