title: Can harmonic focus curved shear effectively seal the pancreatic ducts and prevent pancreatic leak? Feasibility evaluation and testing in ex vivo and in vivo porcine models.
abstract: BACKGROUND
  The purpose of this study was to evaluate the ability of Harmonic energy technology to transect and seal the pancreatic duct compared with the standard monopolar electrosurgery transection and oversew technique in a porcine distal pancreatectomy survival model. Harmonic energy technology is as effective as standard oversew technique for preventing pancreatic leak after distal pancreatectomy.
  
  
  METHODS
  The animal protocol used for this study was approved by the Institutional Animal Care and Use Committee (IACUC) prior to the conduct of the study. Spleen-preserving distal pancreatectomy was performed in seven pigs (80-100 lb) by the same surgeon. In four animals, the pancreas was divided with the Harmonic Focus Curved Shears (test group) with no additional suturing for control of hemostasis or leak. In three animals, the pancreas was divided using monopolar electrosurgery (30 W coagulation) and the cut end of the pancreas was oversewn with a locking suture (control group). A previously worked out standard operative technique was used in all procedures. Operating end points included surgery time and blood loss. Animals were euthanized and necropsied at 7 to 8 d following surgery. Survival endpoints included clinical response to surgery, serum chemistry profiles before surgery and at necropsy, and histology of the pancreas transection site.
  
  
  RESULTS
  Mean operative time for pancreatic resection was 15min in the control group and 10min in the test group. No significant blood loss was noted in either group. The median size of the resected pancreas was 4.3 cm. Three animals in the control group and three in the test group completed the study without complications. One animal in the test group failed to eat, appeared dehydrated, and was taken off study on POD#2. In this animal, there was a doubling of serum lipase at euthanasia and gross evidence of ileus, which was attributed to a pancreatic leak. Histologic examination of the residual pancreas in both groups at necropsy revealed a 2-5 mm band of necrotic tissue associated with neutrophilic infiltration in the control group, and less than a 1mm band of necrotic tissue in the test group.
  
  
  CONCLUSIONS
  The Harmonic Focus Curved Shears, using Harmonic energy technology, appears to seal the pancreatic ducts and prevent pancreatic leak at 75% (3/4) efficiency in this survival model. However, the survival leak rate, 25% (1/4) was higher in the Harmonic Focus Curved Shears test group compared with the control oversewn group 0% (0/3). This feasibility study shows potential for Harmonic technology to be used to seal the pancreatic ducts, but additional testing and optimization of surgical techniques are needed.
authors.affiliation: Department of Surgery, Saint Barnabas Medical Center, Livingston, New Jersey 07039, USA. rchamberlain@sbhcs.com
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Chamberlain
authors.forename: Donna
authors.initials: D
authors.lastname: Korvick
authors.forename: Mary
authors.initials: M
authors.lastname: Mootoo
authors.forename: Sara
authors.initials: S
authors.lastname: Story
authors.forename: Beata
authors.initials: B
authors.lastname: Dubiel
authors.forename: Douglas
authors.initials: D
authors.lastname: Sharpnack
mesh_terms: D000818:Animals; D004598:Electrosurgery / Q000379:methods / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D006488:Hemostasis, Surgical / Q000379:methods; D008026:Ligation; D023421:Models, Animal; D010180:Pancreatectomy / Q000379:methods* / Q000401:mortality; D010183:Pancreatic Ducts / Q000601:surgery*; D015996:Survival Rate; D013537:Sutures; D013552:Swine; D014464:Ultrasonic Therapy / Q000379:methods* / Q000401:mortality