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Trial Title:
Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound
NCT ID:
NCT05617872
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Acetic Acid
Conditions: Keywords:
pancreatic cancer
Endoscopic ultrasound
pancreatic juice
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Vinegar 20ml
Description:
20ml vinegar infused into duodenum and suction for 5 minutes via EUS
Arm group label:
Vinegar 20ml
Intervention type:
Drug
Intervention name:
Saline
Description:
20ml saline infused into duodenum and suction for 5 minutes via EUS
Arm group label:
Saline
Intervention type:
Drug
Intervention name:
Vinegar 40ml
Description:
40ml vinegar infused into duodenum and suction for 5 minutes via EUS
Arm group label:
Vinegar 40ml
Intervention type:
Drug
Intervention name:
Vinegar 20ml, 3 phases
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.
Arm group label:
Vinegar 20ml, 0-5min
Arm group label:
Vinegar 20ml, 10-15min
Arm group label:
Vinegar 20ml, 5-10min
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Xi Wu, M.D.
Phone:
+8613683296860
Email:
wxpumch@163.com
Start date:
November 1, 2022
Completion date:
November 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05617872
