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

NCT04794140 | Unknown

• 1 other identifier: 2021EUS-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Differences in the success rate of culturing primary cells

  Differences in the success rate of pancreatic cancer primary cells (P1) and culture to the third generation (P3) between the two groups.

  About 6 weeks after operation

• The difference in the representation to the original tumor between the two groups of primary cells

  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 (1)

• The relationship between the success rate of primary cell culture and some tumor characteristics

  About 6 weeks after operation

Study Arms (2)

one pass group

EXPERIMENTAL

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.

Procedure: different number of passes

two passes group

EXPERIMENTAL

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.

Procedure: different number of passes

Interventions

different number of passes 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.)

one pass group; two passes group

Eligibility Criteria

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

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
• 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 × 1012, 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

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 11, 2021
• Study Start: January 15, 2021
• Primary Completion: October 31, 2021
• Study Completion: January 31, 2022
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)