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Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

NCT ID: NCT05617872

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2025-12-31

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.

Conditions

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Pancreatic Cancer

Keywords

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pancreatic cancer Endoscopic ultrasound pancreatic juice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Normal Saline Group

Inject 20ml normal saline solution into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes.

Group Type PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type 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 20ml Group

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.

Group Type EXPERIMENTAL

Vinegar 20ml

Intervention Type 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 40ml Group

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.

Group Type ACTIVE_COMPARATOR

Vinegar 40ml

Intervention Type 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.

Interventions

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Vinegar 20ml

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.

Intervention Type DRUG

Saline (NaCl 0,9 %) (placebo)

Inject 20ml normal saline solution into duodenum and collect the pancreatic juice for 15 minutes via EUS, changing the collection bottle every 5 minutes.

Intervention Type DRUG

Vinegar 40ml

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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wu Xi

Associated Professor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xi Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wen Shi, M.D.

Role: CONTACT

Phone: +8613699256758

Email: [email protected]

Facility Contacts

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Xi Wu, M.D.

Role: primary

Other Identifiers

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K2379

Identifier Type: -

Identifier Source: org_study_id