Laser Tissue Welding - Distal Pancreatectomy Sealing Study (LTW)
Pancreatic Tumor, Benign, Pancreatic Neoplasms, Pancreatic Adenocarcinoma
About this trial
This is an interventional device feasibility trial for Pancreatic Tumor, Benign focused on measuring Laser Tissue Welding, Pancreatic Sealing, Hemostasis, Pancreatic Tumors, Pancreatic Resection, Pancreatic leakage, LTW
Eligibility Criteria
Inclusion Criteria:
Eligible participants will be 18 years and older of both genders.
- T1a (≤ 4 cm, as measured by the maximal dimension by CT or MRI). Final determination of disease stage is made during the operation by the investigator. All resectable cystic, benign, primary or secondary malignant tumors.
- Serum creatinine: ≤ 2.5 mg/dL
- Glomerular filtration rate greater than ≥ 50 ml/min/m2
- Platelet count ≥ 50,000/mm3
- Prothrombin time < 18 seconds
- PTT not >1.5 times control (except for therapeutically; anticoagulated nonrelated medical conditions [e.g., atrial fibrillation]);
- Serum albumin levels > 3g/dL (Normal range 3.5 to 5 g/dL)
Exclusion Criteria:
- Age younger than 18 years' old
- Severe uncorrected hypertension (> 180 systolic and >110 diastolic)
- Uncorrectable coagulopathies (on Plavix, Aspirin or Lovanox)
- Pregnancy
- Females who are breast feeding who do not switch the infant to formula prior to surgery
- Active urinary tract infection
- T1b (>4 cm) lesion and above
- Systemic or local infection.
- Subject has known allergy or intolerance to iodine or human serum albumin.
- Recent febrile illness that precludes or delays participation preoperatively.
- Treatment with another investigational drug or other intervention during the study and follow-up period.
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Sites / Locations
- Baylor CHI St. Luke's Medical Center
Arms of the Study
Arm 1
Experimental
Distal Pancreatectomy Sealing using LTW
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.