JCOG2202: Randomized phase III trial of laparoscopic versus open distal pancreatectomy for pancreatic cancer
- Conditions
- Resectable pancreatic cancer
- Registration Number
- JPRN-jRCT1031220705
- Lead Sponsor
- akamura Masafumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 370
(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.
(4) Muximum length of the tumor <= 8 cm.
(5) Curative resection is possible by distal pancreatectomy with regional lymph node dissection.
(6) In case of the preceding diagnostic laparoscopy, peritoneal cytology is negative.
(7) No invasion to the portal vein or other organs except for the adrenal gland or spleen.
(8) Aged between18 and 85 years old.
(9) Performance status (ECOG) of 0 or 1.
(10) No prior treatment of radiation therapy against pancreatic cancer.
(11) No history of upper abdominal surgery except for laparoscopic cholecystectomy.
(12) Sufficient organ functions.
(13) Written informed consent.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method