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Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vinegar 20ml
Saline
Vinegar 40ml
Vinegar 20ml, 3 phases
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pancreatic Cancer focused on measuring pancreatic cancer, Endoscopic ultrasound, pancreatic juice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Saline

Vinegar 20ml

Vinegar 40ml

Vinegar 20ml, 0-5min

Vinegar 20ml, 5-10min

Vinegar 20ml, 10-15min

Arm Description

20ml saline infused into duodenum and suction for 5 minutes via EUS

20ml vinegar infused into duodenum and suction for 5 minutes via EUS

40ml vinegar infused into duodenum and suction for 5 minutes via EUS

20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the first 5 minutes

20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the 5-10 minutes

20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the 10-15 minutes

Outcomes

Primary Outcome Measures

cfDNA concentration
cfDNA concentration of collected pancreatic juice of patients in different arms

Secondary Outcome Measures

PLA2G1B concentration
PLA2G1B concentration of collected pancreatic juice of patients in different arms
Immunoglobulin (Ig) concentration
Immunoglobulin (Ig) concentration of collected pancreatic juice of patients in different arms
KRAS mutation load
KRAS mutation load detected of collected pancreatic juice of patients in different arms
Weight
weight in grams of collected pancreatic juice of patients in different arms

Full Information

First Posted
November 6, 2022
Last Updated
November 15, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05617872
Brief Title
Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound
Official Title
Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, Endoscopic ultrasound, pancreatic juice

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
20ml saline infused into duodenum and suction for 5 minutes via EUS
Arm Title
Vinegar 20ml
Arm Type
Experimental
Arm Description
20ml vinegar infused into duodenum and suction for 5 minutes via EUS
Arm Title
Vinegar 40ml
Arm Type
Active Comparator
Arm Description
40ml vinegar infused into duodenum and suction for 5 minutes via EUS
Arm Title
Vinegar 20ml, 0-5min
Arm Type
Active Comparator
Arm Description
20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the first 5 minutes
Arm Title
Vinegar 20ml, 5-10min
Arm Type
Active Comparator
Arm Description
20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the 5-10 minutes
Arm Title
Vinegar 20ml, 10-15min
Arm Type
Active Comparator
Arm Description
20ml vinegar infused into duodenum and pancreatic juice collected via EUS suction during the 10-15 minutes
Intervention Type
Drug
Intervention Name(s)
Vinegar 20ml
Intervention Description
20ml vinegar infused into duodenum and suction for 5 minutes via EUS
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
20ml saline infused into duodenum and suction for 5 minutes via EUS
Intervention Type
Drug
Intervention Name(s)
Vinegar 40ml
Intervention Description
40ml vinegar infused into duodenum and suction for 5 minutes via EUS
Intervention Type
Drug
Intervention Name(s)
Vinegar 20ml, 3 phases
Intervention Description
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.
Primary Outcome Measure Information:
Title
cfDNA concentration
Description
cfDNA concentration of collected pancreatic juice of patients in different arms
Time Frame
The collected pancreatic juice will be tested in 6 months.
Secondary Outcome Measure Information:
Title
PLA2G1B concentration
Description
PLA2G1B concentration of collected pancreatic juice of patients in different arms
Time Frame
The collected pancreatic juice will be tested in 6 months.
Title
Immunoglobulin (Ig) concentration
Description
Immunoglobulin (Ig) concentration of collected pancreatic juice of patients in different arms
Time Frame
The collected pancreatic juice will be tested in 6 months.
Title
KRAS mutation load
Description
KRAS mutation load detected of collected pancreatic juice of patients in different arms
Time Frame
The collected pancreatic juice will be tested in 6 months.
Title
Weight
Description
weight in grams of collected pancreatic juice of patients in different arms
Time Frame
The pancreatic juice will be weighed instantly 1 day (once) collected by EUS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Shi, M.D.
Phone
+8613699256758
Email
ysfn_2005@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Wu, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wu, M.D.
Phone
+8613683296860
Email
wxpumch@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

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