TEP 3D study

Not Applicable

• Conditions: pancreatic cancer, pancreatitis, esophageal varices, pancreatic cysts, esophageal/gastric cancer

• Registration Number: JPRN-jRCTs042180091
• Lead Sponsor: Ishikawa Takuya

Brief Summary

We presented the first case report that demonstrated the usefulness of 3D TEE in characterizing MCN of the pancreas. Our experience has indicated the possibility to apply real-time 3D ultrasonography for the assessment of pancreatic lesions. We hope an EUS probe equipped with a matrix transducer such as TEE will be developed in the near future.

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-02-20
• Study Start: 2019-03-13
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

(1) Patients who have lesions in the esophagus or periesophageal region (e.g. lymph nodes, pancreas, liver) which can be observed with EUS. Specific examples are as follows:
1. Pancreatic cancers that require evaluation of invation to vessels.
2. Esophageal/gastric varices that need to select appropriate location for sclerosing therapy or require evaluation of therapeutic effect.
3. Acute pancreatitis that require evaluation of blood flow inside the pancreas
4. Pancreatic cystic neoplasms that require detailed evaluation of internal structures (real-time evaluation of nodule, septum and mucus excluding partial volume effect).
5. Early stage esophageal/gastric cancers that require three dimentional evaluation of external wall vessels prior to endoscopic resection.
(2) Patients between 20 and 80 years old at the time of enrollment.
(3) Preservation of main organ functions at the time of diagnosis.
(4) Provision of written consent to participate in the study.

Exclusion Criteria

(1) Serious adverse events.
(2) Severe mental disorder
(3) Judgement as being ineligible by the principal or subinvestigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in images between EUS and TEE and concordance rate with histopathological findings (limited to those with pathology).

Secondary Outcome Measures

Name	Time	Method
Complication rate of EUS<br>Complication rate of TEE