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

NCT ID: NCT04797676

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-02-28

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.

Detailed Description

Pancreatic cancer is one of the malignant tumors with the highest mortality rate in the world, with a 5-year survival rate of only 7.2%-9%. Because some patients are resistant to multiple chemotherapy drugs, and there are differences in drug sensitivity between individuals, the current pancreatic ductal adenocarcinoma (PDAC) chemotherapy effect is not satisfactory. In order to improve the efficacy of chemotherapy and achieve precise treatment, it is important to establish an accurate and individualized PDAC research model.

At present, several studies have reported that surgical specimens of pancreatic cancer are successfully used to cultivate preclinical research models. However, most patients with PDAC have developed to advanced stage at the time of diagnosis and are not suitable for surgery, which limits our ability to obtain tumor cells. Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) can procure specimens when patients have not receive any treatment, and can also evaluate the therapeutic effect and tumor progression in the process of treatment.

Until now, there is no study to compare the efficiency of the two methods in constructing preclinical research model of pancreatic cancer. Therefore, the investigators intend to investigate the difference in the success rate of culturing primary cells derived from PDAC specimens of patients which obtained by EUS-FNB 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 PDAC patients to choose the source of individual treatment samples.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

different methods of specimen acquisition

Intervention Type: 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.

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.

different methods of specimen acquisition

Intervention Type: 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.

Interventions

different methods of specimen acquisition

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Male or female, age≥18

2. 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

3. No chemotherapy, including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy, has been performed on patients

4. Having surgery opportunities (including radical operation and cytoreductive surgery) and willingness of operation

5. Agree to attend this study and signed informed consent

Exclusion Criteria

1. Poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc

2. Coagulation dysfunction (platelet count < 50,000/mm3, international standardized ratio > 1.5), or inability to discontinue anticoagulation therapy

3. High risk for deep sedation

4. Acute pancreatitis in the previous 2 weeks

5. Pregnancy or lactation

6. Any diseases leading to unreliable follow-up

7. Absence of informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyan Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital, Central South University

Locations

The Third Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Wang, M.D.

Role: CONTACT

tingtong@csu.edu.cn

+8613974889301

Ting Tong, M.D.

Role: CONTACT

89588355@163.com

+8613247360862

Facility Contacts

Xiaoyan Wang, M.D.

Role: primary

tingtong@csu.edu.cn

+8613974889301

Ting Tong, M.D.

Role: backup

89588355@163.com

+8613247360862

Other Identifiers

2021EUS-002

Identifier Type: -

Identifier Source: org_study_id