JPRN-jRCT1031220705
Recruiting
Phase 3
JCOG2202: Randomized phase III trial of laparoscopic versus open distal pancreatectomy for pancreatic cancer - LAPAN study
akamura Masafumi0 sites370 target enrollmentMarch 14, 2023
ConditionsResectable pancreatic cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Resectable pancreatic cancer
- Sponsor
- akamura Masafumi
- Enrollment
- 370
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Pancreatic tumor diagnosed by contrast\-enhanced abdominal computed tomography (CT) meeting either one of the following conditions.
- •(i) Histologically proven invasive ductal carcinoma (adenocarcinoma or adenosquamous carcinoma)
- •(ii) Cytologically proven Class IV or Class V
- •In case of the following conditions, pancreatic tumor radiologically compatible with invasive ductal carcinoma is eligible without pathological diagnosis.
- •(a) No neoadjuvant chemotherapy
- •(b) Endoscopic ultrasound\-guided tissue acquisition or endoscopic retrograde cholangiopancreatography can not be performed safely.
- •(2\) Tumor located in the body or tail of the pancreas.
- •(3\) Resectable pancreatic cancer by contrast\-enhanced CT. Patients treated with preoperative chemotherapy fulfill both (i) and (ii).
- •(i) Resectable pancreatic cancer before chemotherapy.
- •(ii) Resectable pancreatic cancer after chemotherapy.
Exclusion Criteria
- •(1\) Synchronous or metachronous (within 5 years) malignancies.
- •(2\) Infectious disease that requires systemic treatment.
- •(3\) Body temperature of 38\.0 degrees Celsius or higher.
- •(4\) During pregnancy, within 28 days of postparturition, or during lactation.
- •(5\) Severe mental disease.
- •(6\) Receiving continuous systemic corticosteroid or immunosuppressive treatment.
- •(7\) Severe comorbidities (such as heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal obstruction, and poorly controlled hypertension).
- •(8\) History of unstable angina pectoris within3 weeks or myocardial infarction within 6 months before registration.
- •(9\) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest X\-ray.
- •(10\) Iodide is not allowed because of allergy, renal failure, or bronchial asthma.
Outcomes
Primary Outcomes
Not specified
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