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Table 1 Eligibility criteria

From: ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial

Inclusion criteria

Exclusion criteria

(1) Patients who have been diagnosed with resectable pancreatic cancer (adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma) according to the Classification of Pancreatic Carcinoma of Japan Pancreas Society (Fourth English Edition) [18] and the National Comprehensive Cancer Network (NCCN) definition 2020 [19], excluding invasive intraductal papillary mucinous carcinoma (IPMC) by image diagnosis at the initial diagnosis, and for whom body-tail pancreatectomy or tail pancreatectomy is planned. Preoperative biopsy is not mandatory, however, and allows clinical diagnosis.

(2) ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1–3.

(3) Age over 20 years.

(4) Patient has sufficient judgment to understand the content of the research and has provided written consent.

(1) Patients who have not been diagnosed with resectable pancreatic cancer by image diagnosis as the initial diagnosis.

(2) Patients with tumor suspected of portal vein (superior mesenteric vein) invasion.

(3) Patients with severe ischemic heart disease.

(4) Patients with cirrhosis or active hepatitis requiring treatment.

(5) Patients with dyspnea requiring oxygen administration.

(6) Patients undergoing dialysis due to chronic renal failure.

(7) Patients with tumor for which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary.

(8) Patients with strong suspicion of paraaortic lymph node metastasis.

(9) Patients with active double cancer thought to affect adverse events and prognosis.

(10) Patients with usage of long-term oral steroids that may affect adverse events.

(11) Patients considered to have potential difficulty participating in the study due to psychosis or psychiatric symptoms.

(12) Cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. Invasive pancreatic ductal carcinoma is classified into four types: adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma, and invasive intraductal papillary mucinous carcinoma (IPMC) is excluded. However, a preoperative biopsy is not mandatory.

(13) Patients who cannot use either iodine and gadolinium contrast agent due to severe drug allergy.

(14) Patients whose abdomen makes it difficult to perform the prescribed procedure due to a history of upper abdominal surgery, such as on the stomach, spleen, kidney, liver, transverse colon, or retroperitoneum, including the pancreas and for pancreatitis.

(15) Patients who may require resection of organs other than the spleen, left adrenal gland, and gallbladder.

  1. Abbreviations: ASA-PS American Society of Anesthesiologists-Physical Status