25G and 22G Puncture Needles

• Conditions: Submucosal Tumor; Pancreas Tumor

• Registration Number: NCT05101772
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-18
• Study Start: 2021-09-24
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-08
• Primary Completion: 2022-04-24
• Study Completion: 2022-05-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The acquisition rate of the core tissue sample	One week	A core tissue sample is defined as a sample with an histological structure that is fully used for tissue evaluation of target lesions.

Secondary Outcome Measures

Name	Time	Method
The length of the tissue strip	One week	The quality of tissue samples obtained by puncture is assessed by the pathologist, whether intact tissue structure is preserved, and the length of tissue strips
the incidence of adverse events and the incidence of device defects	one week	Adverse events refer to adverse medical events that occur in the course of research, including punctured complications such as bleeding, abdominal pain, infection, pancreatitis, etc. throughout the study process.
the technical success rate 、the success rate of immunogrouping dyeing and the retention of the organizational structure	One week	The quality of tissue samples obtained by punctures is evaluated by pathologists, technical success means that puncture 2 needles can obtain sufficient tissue samples for analysis to be evaluated by endoscopy.

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China