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JCOG2202: Randomized phase III trial of laparoscopic versus open distal pancreatectomy for pancreatic cancer (LAPAN study)

JCOG2202: Randomized phase III trial of laparoscopic versus open distal pancreatectomy for pancreatic cancer (LAPAN study)

Nakamura Masafumi

Kyushu University Hospital

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN

nakamura.masafumi.861@m.kyushu-u.ac.jp

Ikenaga Naoki

Kyushu University Hospital

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN

+81-92-642-5441

ikenaga.naoki.533@m.kyushu-u.ac.jp

Recruiting

Mar. 14, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(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 by contrast-enhanced CT before initiation of chemotherapy.
(ii) Resectable pancreatic cancer by the last contrast-enhanced CT after initiation of 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 or percutaneous peritoneal lavage, 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 2years) 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.

Both

Resectable pancreatic cancer

Arm A: Open distal pancreatectomy with regional lymph node dissection + adjuvant chemotherapy (S-1 x 4 cycle)
Arm B: Laparoscopic distal pancreatectomy with regional lymph node dissecton + adjuvant chemotherapy (S-1 x 4 cycle)
*Robot-assisited distal pancreatectomy is allowed in arm B
*S-1: 80-120 mg/body, day 1-28, by mouth, twice daily

Overall survival

Recurrence-free survival, Proportion of patients with R0 resection, Operation time, Estimated blood loss, Maximum incision length, Proportion of patients with completion of laparoscopic surgery, Incidence of surgical adverse events, Perioperative mortality rate, Length of postoperative hospital stay

+81-3-3542-2511

Jan. 26, 2023

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