Laser Tissue Welding - Distal Pancreatectomy Sealing Study (LTW)
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|ClinicalTrials.gov Identifier: NCT03147768|
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : August 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Device: Distal Pancreatectomy Sealing Using LTW||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label Combination Product (Laser + Biologic + Drug) regulated as a device|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Phase I Feasibility Trial To Study The Safety Of Sealing Resected Pancreatic Surfaces After Partial Distal Pancreatectomy Using Laser Tissue Welding|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
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.
Device: Distal Pancreatectomy Sealing Using LTW
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.
- PRIMARY EFFICACY AS A SEALANT: Intra-operative blood loss [ Time Frame: Intra-operative ]
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 SAFETY: Post-operative blood loss requiring return to the operating room [ Time Frame: 30 days ]Secondary hemorrhage or intra-abdominal hematoma requiring surgical evacuation
- SECONDARY SAFETY: Prolonged post-operative pancreatic leakage [ Time Frame: 30 days ]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 SAFETY: Surgical space abscess [ Time Frame: 30 days ]Secondary infection, intra-abdominal abscess formation requiring surgical evacuation
- SECONDARY EFFICACY: Total operating time (minutes) [ Time Frame: Intra-operative assessment ]Duration and Cost Metric
- SECONDARY EFFICACY: Pancreas clamp time (minutes) [ Time Frame: Intra-operative assessment ]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)
- SECONDARY EFFICACY: Laser tissue welding time or time to hemostasis (Duration Metric) [ Time Frame: Intra-operative assessment ]Duration and Cost Metric
- SECONDARY EFFICACY: Length of ICU stays (Duration and cost Metric ) [ Time Frame: 30 days ]Duration and Cost Metric
- SECONDARY EFFICACY: Total hospital stay (Duration and cost Metric ) [ Time Frame: 3 months ]Duration and Cost Metric
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147768
|Contact: OMAR BARAKAT, M.D.||firstname.lastname@example.org|
|Contact: BRIDGET SOLISemail@example.com|
|Principal Investigator:||OMAR BARAKAT, M.D||Baylor CHI St. Luke's Medical Center, Houston, Texas|
|Study Director:||STEPHEN HAROLD, M.D.; MPH; CCRC||Baylor CHI St. Luke's Medical Center, Houston, Texas|