Paclitaxel injection therapy for pancreatic cyst

JRCT ID: jRCTs041220072

Registered date:14/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cystics lesion
• Date of first enrollment: 14/10/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Paclitaxel injection under endoscopic ultrasonography for pancreatic cystic lesions.

Outcome(s)

• Primary Outcome: To confirm the safety of endoscopic ultrasound-guided paclitaxel infusion therapy for pancreatic cystic lesions.
• Secondary Outcome: To confirm the efficacy of endoscopic ultrasound-guided paclitaxel infusion therapy for pancreatic cystic lesions.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1.Patients aged 20 years or older and 75 years or younger at the time of obtaining informed consent.
2.Patients who given their written consent to participate in this study.
3.Patients diagnosed with the pancreatic cystic lesion.
4.Patients with cyst diameter of 10 mm or more and less than 50 mm measuring by CT or MRI.
5.Patients with unilocular or oligolocular (4 or fewer locules) cyst morphology.
6.Patients whose performance status are 0 to 1.
7.Patients who are not indicated for surgery or refuse surgery in spite of having a certain degree of prognosis.

Exclude criteria

1.Patients with a history of allergy to paclitaxel.
2.Patients with cystic lesions obviously suspected of malignancy in the image findings.
3.Patients with cystic lesions obviously suspected of pseudocyst or retention cyst in the image findings.
4.The blood test results within 28 days before registration correspond to the following.
(1)Prothrombin time <= 50% or international normalized ratio >= 1.5.
(2)Platelet count <= 50000/mm3
5.Patients taking 2 or more antithrombotic drugs.
6.Patients who are pregnant or have possibility of pregnancy.
7.Patients who are not expected to survive for at least 5 years.
8.Patients who are deemed unsuitable for participating in this study for other reasons.

Related Information

• Primary Sponsor: Kazuo Hara