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A Prospective Randomized Clinical Trial

Takehiro Okabayashi, MD; Isao Nishimori, MD; Koichi Yamashita, MD; Takeki Sugimoto, MD; Hiromichi Maeda, MD; Tomoaki Yatabe, MD; Takuhiro Kohsaki, MD; Michiya Kobayashi, MD; Kazuhiro Hanazaki, MD

Arch Surg. 2009;144(10):933-937.

Objective  To evaluate a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Design  Prospective, randomized clinical trial.

Patients  Thirty patients who had pancreatic resection for pancreatic neoplasm.

Interventions  Patients were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method (sliding scale group, n = 13) or the artificial pancreas (artificial pancreas group, n = 17).

Main Outcome Measures  Incidence of severe hypoglycemia (<40 mg/dL) during the intensive care period following pancreatic resection in patients monitored with the artificial pancreas. The secondary outcome measure was the total amount of insulin required for glycemic control in the first 18 hours after pancreatic resection in each patient group.

Results  In the sliding scale group, postoperative blood glucose levels rose initially before reaching a plateau of approximately 200 mg/dL between 4 and 6 hours after pancreatectomy. The levels remained high for 18 hours postoperatively. In the artificial pancreas group, blood glucose levels reduced steadily, reaching the target zone (80-110 mg/dL) by 6 hours after surgery. The total insulin dose administered per patient during the first postoperative 18 hours was significantly higher in the artificial pancreas group (mean [SD], 107 [109] IU) than the sliding scale group (8 [6] IU; P < .01). Neither group showed hypoglycemia.

Conclusions  Perioperative use of an artificial endocrine pancreas to control pancreatogenic diabetes after pancreatic resection is an easy and effective way to maintain near-normal blood glucose levels. The artificial pancreas shows promise for use as insulin treatment for patients with pancreatogenic diabetes after pancreatic resection.

Author Affiliations: Departments of Surgery (Drs Okabayashi, Sugimoto, Maeda, Yatabe, and Hanazaki), Gastroenterology and Hepatology (Drs Nishimori and Kohsaki), Anesthesiology and Critical Care Medicine (Dr Yamashita), and Clinical Health and Medical Services, Kochi Medical School, Kochi, Japan (Dr Kobayashi).

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