NCT05954221

Brief Summary

The goal of this clinical trial is to evaluate the application of red cell lysis buffer (RCLB) versus conventional sample processing in endoscopic ultrasonography (EUS)-guided biopsy for solid pancreatic lesions. The main questions it aims to answer are: whether the application of red cell lysis buffer improves histological tissue quality by decreasing blood contamination. Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-guided biopsy. The obtained specimens will be processed by RCLB and conventional formalin solution. Researchers will compare the blood contamination score of specimens in RCLB group with the conventional group see if the blood contamination can be improved.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

July 12, 2023

Last Update Submit

September 5, 2023

Conditions

Pancreatic Diseases

Keywords

EUS-FNBsample processingsolid pancreatic lesion

Outcome Measures

Primary Outcomes (1)

  • Microscopic blood contamination assessments

    Microscopic blood contamination is assessed by grading the percentage of the area of the blood cells in the entire ×40 field of view (score 3, \< 25 %; score 2, 25 % - 50%; score 1, \> 50 %; score 0, no material)

    2 months

Secondary Outcomes (8)

  • Tissue integrity assessments

    2 months

  • Macroscopic blood contamination assessments

    2 months

  • Length of white core tissue

    2 months

  • Diagnostic sensitivity

    2 months

  • Diagnostic accuracy

    2 months

  • +3 more secondary outcomes

Study Arms (2)

Red cell lysis buffer (RCLB) group

EXPERIMENTAL

Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be processed with red cell lysis buffer and underwent histological evaluation.

Procedure: Red cell lysis buffer (RCLB) application

conventional group

ACTIVE COMPARATOR

Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be fixed with formalin as usual and underwent histological evaluation.

Procedure: Conventional processing

Interventions

Red cell lysis buffer (RCLB) applicationPROCEDURE

The tissue is lysed with 50% concentration of RCLB for 15 min on a shaking device. If the lysis is judged to be insufficient, it can be repeated one more time. Finally, the treated tissue will be fixed with 10% formalin.

Red cell lysis buffer (RCLB) group
Conventional processingPROCEDURE

The tissue is fixed with 10% formalin.

conventional group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years old; Solid pancreatic lesions confirmed by clinical and CT/MRI/ PET imaging. Signed written informed consent

You may not qualify if:

  • Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant Patient is enrolled in any other clinical protocol or investigational trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Zhao Shen Li, M.D

    Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Yi Ma, M.D

CONTACT

+8613621819595504043536@qq.com

Kai Xuan Wang, M.D

CONTACT

wangkaixuan224007@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Gastroenterology, Changhai Hospital

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 20, 2023

Study Start

September 15, 2023

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)