Laser Tissue Welding - Distal Pancreatectomy Sealing Study
United States11 participantsStarted 2018-01-01
Plain-language summary
The laser tissue welding device is intended for use in patients requiring sealing of the pancreas after partial pancreatectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure.
The hypothesis is that the laser tissue welding device is safe and effective in sealing the pancreas, thereby decreasing the blood loss (operative and post-operative), and pancreatic juice leakage for patients when the Laser Tissue Welding device is used after pancreatic resection.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✕
What they're measuring
1
PRIMARY EFFICACY AS A SEALANT: Intra-operative blood loss