UTEP 3D study

JRCT ID: jRCTs042180091

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: pancreatic cancer, pancreatitis, esophageal varices, pancreatic cysts, esophageal/gastric cancer
• Date of first enrollment: 23/01/2018
• Target sample size: 50
• Study type: Interventional
• Intervention(s): In this study, TEE will be performed subsequently to normal observation by EUS. Use of TEE for digestive diseases is not coverd by insurance and as the probe will be inserted into the esophagus twice, which is orignially once, the adverse events may increase with the procedure. The procedure time will be also prolonged by 10 to 15 minutes.

Outcome(s)

• Primary Outcome: Difference in images between EUS and TEE and concordance rate with histopathological findings (limited to those with pathology).

Secondary Outcome

Complication rate of EUS
Complication rate of TEE

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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.

Exclude criteria

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

Related Information

• Primary Sponsor: Ishikawa Takuya