A Clinical Study to Evaluated Which Number of Passes of EUS-FNB is Better for Culturing Primary Cells of PDAC

NCT ID: NCT04794140

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-01-31

Brief Summary

The Aim of this study is to investigate the amount of tissue required for the successful culture of primary cells from human-derived pancreatic ductal adenocarcinoma which obtained by endoscopic ultrasound-guided fine-needle biopsy wet suction technique

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.

Because most of patients with PDAC have developed to advanced stage at the time of diagnosis, it is not suitable for surgery. That limits our ability to obtain tumor cells seriously. With the development of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) technique, it can be used not only to diagnose diseases, but also to provide specimens for molecular analysis and create valuable preclinical disease research models, so as to guide the selection of the most appropriate individualized treatment. EUS-FNB can obtain lesions without any treatment. Therefore, the preclinical disease research model established by EUS-FNB is more representative of the original tumor.

However, compared with surgical specimens, the specimens obtained by EUS-FNB are smaller in size, which may affect the successful construction of research models in vitro. Therefore, the investigators plan to use EUS-FNB wet suction technique, a modified specimen acquisition method, to obtain PDAC tissue, and use it for primary cell culture, to explore the amount of tissue required for the successful cultivation of human-derived pancreatic cancer primary cells, so as to provide a prerequisite for the successful establishment of human-derived preclinical disease research model.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

one pass group

We use the endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique to procure the specimens, and use the sample obtained from a single pass for primary cell culture. EUS-FNB wet suction technique refer from Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.

Group Type: EXPERIMENTAL

different number of passes

Intervention Type: PROCEDURE

Each patient's operation process is the same, that is, after obtaining enough specimens for diagnosis by endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique, additional three passes are performed. One of which is randomly selected as the one pass group, and the other two passes automatically as the two pass group. Please refer to the literature for EUS-FNB wet technique (Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.)

two passes group

We use the endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique to procure the specimens, and use the sample obtained from two passes for primary cell culture. EUS-FNB wet suction technique refer from Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.

Group Type: EXPERIMENTAL

different number of passes

Intervention Type: PROCEDURE

Each patient's operation process is the same, that is, after obtaining enough specimens for diagnosis by endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique, additional three passes are performed. One of which is randomly selected as the one pass group, and the other two passes automatically as the two pass group. Please refer to the literature for EUS-FNB wet technique (Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.)

Interventions

different number of passes

Each patient's operation process is the same, that is, after obtaining enough specimens for diagnosis by endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique, additional three passes are performed. One of which is randomly selected as the one pass group, and the other two passes automatically as the two pass group. Please refer to the literature for EUS-FNB wet technique (Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.)

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. 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 × 1012, 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-001

Identifier Type: -

Identifier Source: org_study_id