At the completion of pancreatic resection, the cut surface of the pancreas is covered with two layers of Albu-Green solder and one layer of D-Albumin lamina, all welded with the laser. The 60 Watt custom 810nm diode laser, is set to deliver continuous energy with laser irradiation power of approximately 150 W/cm2 with a Fluence of 90 J/cm2. During soldering the tip of the custom hand piece with top hat beam profile is held 1-2 cm from the wound surface to generate a 5mm spot size. Albu-Green Solder is observed to convert from a liquid green state to a solid white crust when the laser is activated indicating the completion of welding and providing a visual cue to the operator. The amount of Albu-Green solder and size of the denatured albumin lamina used is documented. The total laser tissue welding time for the three layers and the laser tissue welding time in seconds per cm2 is documented.

Pancreatic Tumor, Benign

Pancreatic Neoplasms

Pancreatic Adenocarcinoma

Pancreatic Pseudocyst

Pancreatic Neuroendocrine Tumor

Pancreas; Insulinoma

Pancreatic Cyst

Pancreatic Teratoma

Pancreatic Polypeptide Tumor

Pancreatic Vipoma

Pancreatic Cystadenoma

Pancreas Injury

Pancreatic Gastrinoma

Pancreatic Glucagonoma

The device's intended use is to seal the pancreatic surface using a laser to weld human albumin based biomaterials after surgical removal of pancreatic tumors during a partial pancreatectomy.

Distal Pancreatectomy Sealing Using LTW

NCI SEERS Register Cancer Stat Facts: Pancreas Cancer

NCI: A Snapshot of Pancreatic Cancer - Incidence and Mortality

Gore SeamGuard staple/suture reinforcement material 510 (k) k043056

Baylor CHI St. Luke's Medical Center

Laser Tissue Welding - Distal Pancreatectomy Sealing Study

Phase I Feasibility Trial To Study The Safety Of Sealing Resected Pancreatic Surfaces After Partial Distal Pancreatectomy Using Laser Tissue Welding

Operative blood loss is defined by: volume of blood in the suction bottles, volume of blood clots, and weight of surgical towels before and after use. Clinical drop in hemoglobin (1 gm% = 300 ml) without hemodilution.
Correlates with intra-operative blood transfusions. Correlates with post-operative blood transfusions.

Secondary hemorrhage or intra-abdominal hematoma requiring surgical evacuation

Pancreatic juice leakage is measured in drainage bottles (ml/day) following surgery till a drain placed during the operation is removed before patient discharge. Accumulation of fluids around the pancreas will be assessed with U/S and CT scan at the mentioned time points.

Secondary infection, intra-abdominal abscess formation requiring surgical evacuation

Duration Metric: Assesses organ ischemia and handling, and will correlate with compromised function (rise in serum Amylase and Lipase) (assesses organ ischemia and will correlate with compromised function)

Laser Tissue Welding, Inc.

National Cancer Institute (NCI)

CHI St. Luke's Health, Texas

Open Label Combination Product (Laser + Biologic + Drug) regulated as a device

subjects will receive a gelofusine injection before the injection of the radiopharmaceutical (111In-exendin 4)

As a control, subjects will receive an injection of saline before the injection of the radiopharmaceutical (111In-exendin 4)

insulinoma/albumin

Laser Tissue Welding - Distal Pancreatectomy Sealing Study

Effect of Gelofusine on GLP1-receptor Imaging

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