25G and 22G Puncture Needles

NCT05101772 | Unknown

• 1 other identifier: HS-2894
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The screened patients were randomly assigned 25G puncture needles and 22G puncture needles in a 1;1 ratio, based on the computer-generated random order, before receiving an ultrasound endoscope puncture. Each puncture needle puncture lesions 2 needles, the same type of puncture needle tissue samples taken in the same tissue pathology bottle, all tissues after the completion of the necessary cytological smears, are placed in the Formalin solution to send tissue pathology, pathologists do not know the order of distribution of 2 puncture needles to evaluate the tissue results, all pathology results are reported by the hospital pathology center, audit.

Conditions

Submucosal Tumor; Pancreas Tumor

Outcome Measures

Primary Outcomes (1)

• The acquisition rate of the core tissue sample

  A core tissue sample is defined as a sample with an histological structure that is fully used for tissue evaluation of target lesions.

  One week

Secondary Outcomes (3)

• The length of the tissue strip

  One week

• the technical success rate 、the success rate of immunogrouping dyeing and the retention of the organizational structure

  One week

• the incidence of adverse events and the incidence of device defects

  one week

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

The subjects were 18 years of age or older (inclusive) who were clinically diagnosed with solid pancreatic masses or submucosal masses and required endoscopic ultrasound-guided puncture examination. Seventy-three subjects are planned to be enrolled.

You may qualify if:

• Clinical diagnosis of real pancreatic swelling or submuscular swelling;
• Patients need to be guided by ultrasound endoscopy under the guidance of puncture to eliminate malignant lesions or clear lesions;
• Fully communicate before surgery, understand the risks and benefits of endoscopic operation, and sign an informed consent form.

You may not qualify if:

• There are endoscopic operation contraindications, including abnormal blood clotting, or long-term oral anticoagulant antiplatelet drugs, can not guarantee INR \< 1.5, or platelets less than 5 x 10 x 9 / L;
• Pregnant woman

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pancreatic or submucosal tissue

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yunlu Feng, Doctor

CONTACT

010-69151591; yunluf@icloud.com

Study Design

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

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: November 1, 2021
• Study Start: September 24, 2021
• Primary Completion: April 24, 2022
• Study Completion: May 24, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-09

Locations

CN (1)