Effects of Different Methods of PDAC Specimen Acquisition on Primary Cell Culture and Application

NCT04797676 | Unknown

• 1 other identifier: 2021EUS-002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the difference in the success rate of culturing primary cells derived from pancreatic ductal adenocarcinoma specimens of patients which obtained by endoscopic ultrasound-guided fine-needle biopsy wet suction technique and surgery, analyze whether the sensitive chemotherapeutic agents screened by the primary cells cultured from the specimens obtained by the above two methods are consistent, and whether they are consistent with the clinical treatment effect of patients, verify the accuracy of laboratory drug sensitivity results, so as to provide the basis for pancreatic ductal adenocarcinoma patients to choose the source of individual treatment samples.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• The different culture success rate

  The difference in the success rate of primary cell culture (P1) and passage to the third generation (P3) between PDAC specimens obtained by EUS-FNB and those obtained by surgery.

  About 6 weeks after operation

• The representation of the primary cells of pancreatic cancer

  Through Western Blot and PCR methods to detect the representativeness of primary cells to the primary tumor. If the patient underwent surgery later, hematoxylin-eosin staining and/or immunohistochemistry were added to compare the histological morphology with the original tumor.

  About 8 weeks after operation

Secondary Outcomes (2)

• Differences in drug susceptibility results between the two groups

  About 14 weeks after operation

• Differences of drug sensitivity results between in vitro and clinical drug results

  About 22 weeks after operation

Study Arms (2)

EUS-FNB group

Each patient participated in the EUS-FNB group and the surgery group. The procedure of EUS-FNB with wet suction technique is as follow: before the needle was inserted into the biopsy channel, the stylet was removed, and the needle was flushed with saline solution until the fluid dripped out of the needle tip. The air column was replaced with the fluid. A 10-mL syringe was prefilled with 2 mL of saline solution, and the valve was closed. The syringe was loaded to the 5-mL position (i.e. a 3-mL vacuum) and then attached to the proximal port and used for biopsy after inserting into the biopsy channel and puncturing the lesion. Each patient was performed 1-2 passes to obtain specimens for subsequent experiments.

Procedure: different methods of specimen acquisition

surgery group

Each patient participated in the EUS-FNB group and the surgery group. The patient underwent EUS-FNB with wet suction technique first, followed by surgery (palliative surgery without excising tumor is not included) for pancreatic cancer. According to the size of the specimen, 0.5cm3-1cm3 tumor specimen was used for subsequent experiments.

Procedure: different methods of specimen acquisition

Interventions

different methods of specimen acquisition PROCEDURE

After informed consent, the investigators use two methods to obtain specimens for patients with pancreatic ductal adenocarcinoma, who needs eus-fnb for auxiliary diagnosis and had the opportunity of surgery. One method is EUS-FNB with wet suction technique, the other is surgery (including radical operation and cytoreductive surgery). Both methods are used on the same patient to remove deviations in results caused by tumor heterogeneity.

EUS-FNB group; surgery group

Eligibility Criteria

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

Study Population

Patients who are considered as PDAC by imaging, and may have opportunity of surgery, and require EUS-FNB for definite diagnosis will potentially be included in this study. Informed consent will be given by the doctor in charge or endoscopic operator or researcher. Patients who agree to participate in the trial will sign an informed consent form. Patients were enrolled after being screened according to the eligibility criteria.

You may qualify if:

• Male or female, age≥18
• Imaging examination (US, MRI, CT or PET-CT) of patients confirmed pancreatic lesions, and considered the possibility of PDAC, EUS-FNB was needed for auxiliary diagnosis
• No chemotherapy, including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy, has been performed on patients
• Having surgery opportunities (including radical operation and cytoreductive surgery) and willingness of operation
• Agree to attend this study and signed informed consent

You may not qualify if:

• Poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc
• Coagulation dysfunction (platelet count \< 50,000/mm3, international standardized ratio \> 1.5), or inability to discontinue anticoagulation therapy
• High risk for deep sedation
• Acute pancreatitis in the previous 2 weeks
• Pregnancy or lactation
• Any diseases leading to unreliable follow-up
• Absence of informed consent

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The investigators use two methods (EUS-FNB and surgery) to obtain pancreatic cancer specimens from patients.

Study Officials

• Xiaoyan Wang, M.D.

  The Third Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Wang, M.D.

CONTACT

+8613974889301; tingtong@csu.edu.cn

Ting Tong, M.D.

CONTACT

+8613247360862; 89588355@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 15, 2021
• Study Start: January 15, 2021
• Primary Completion: November 30, 2021
• Study Completion: February 28, 2022
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)