The pancreas is one of the most challenging organs from a surgical perspective and there is no technology available that effectively seals this organ after resection. The development of pancreatic leakage and fistula is the single most significant cause of morbidity and mortality after pancreatectomy and abdominal sepsis occurs in 30-50% 1, 5 of the postoperative patients. Improvements in anesthesia and perioperative management decreased the surgical mortality to less than 5% for pancreatoduodenectomy,5 unfortunately, the postoperative morbidity remains high and approaches 50% even in large series. For patients undergoing distal pancreatectomy, pancreatic fistulas occurred post-operatively in 31% of patients.7 Over the long term Kazanjian et al 6 analyzed, 182 patients from 1996-2005 who underwent pancreatoduodenectomy to treat ductal adenocarcinoma, concluded that the principal factor influencing long-term survival was operative blood loss. The goal of this application is to test the first-in-human feasibility of sealing the pancreas after distal pancreatectomy using laser tissue welding (LTW). LTW is a laser-biologic combination device which uses a non-compressive, non-ablative technology to join and seal tissues instantly for controlling the leakage of blood, gastrointestinal fluids, urine, bile, lymph, and cerebrospinal fluid. It is life-saving when used on the surfaces of solid visceral organs, such as the liver spleen, pancreas and kidney, involved in trauma, cancer and transplantation in presence of coagulopathies or anticoagulation. Specific Aims 1. Partial proximal & distal pancreatectomy using laser tissue welding: Twelve week GLP preclinical safety and efficacy studies in 18 pigs (Time: 6 months) 2. Partial proximal & distal pancreatectomy using laser tissue welding: Safety and Efficacy Clinical Trial (Time: 18 months) 2.1. Investigational device exemption (IDE) submission and approval for clinical trials, and IRB approval. 2.2. Pilot human feasibility clinica study in 10 patients for distal pancreatectomy indication of use. 2.3. Pilot human feasibility clinical study in 10 patients for pancreaticojejunostomy indication of use. Potential Technology innovation: LTW has developed a combination of a process and two proprietary bioabsorbable human albumin products that are applied to seal tissues to stop fluid leaks such as blood, bile (alkaline), pancreatic (proteolytic) and urine (acidic), during surgical repair of the pancreas, lier and kidney.4, 6 This combination device has laser precision with the versatility to seal tissues without thermal ablation of normal or abnormal tissues. Anticipated Outcomes: Would require the approval of a pre-market market approval (PMA) application with separate IDE applications for each anatomical region, organ and indication of use.
Potential Commercial Applications: LTW may be used to sealing and joining all tissues. Applications include sealing after solid visceral organ trauma and tumor resections; split liver transplants; laparoscopic nephrectomy; urethral repair, hypospadias repair, dural sealing, spinal fusion and difficult dental hemostasis.
Public Health Relevance Statement: Public Health Relevance: The current proposal aims to address a safe and effective method of sealing pancreatic resections without complications arising from pancreatic leakage such as peritonitis, sepsis and death. The current state-of-art pancreatic surgical resections have an unacceptable pancreatic leak rate of 30-50%. This is because there are no FDA cleared or approved sealants or devices found to be safe or effective for sealing this organ. The current standard of care is anything but standard because of the use of off-label devices and sealants. The key determinant of outcome after pancreatoduodenectomy (Whipple procedure) remains the pancreatic enteric anastomosis3. The development of pancreatic leakage and fistula is the single most significant cause of morbidity and mortality after pancreatectomy and abdominal sepsis in 30-50% 1, 5 of the postoperative patients. For patients undergoing distal pancreatectomy, pancreatic fistulas occurred post-operatively in 31% of patients.7 With Laser Tissue Welding technology we hope to eliminate the need for suturing, stapling, buttressing or ablating the pancreas, significantly reduce pancreatic leakage and improve hemostasis, which will improve pancreatic preservation and function. Laser tissue welding (LTW) is an enhanced non-compressive and non- ablative surgical capability that can seal fluid leaks instantly and accurately, including blood, gastrointestinal fluids, urine, bile, lymph, and cerebrospinal fluid. Relevance Laser tissue welding is a transformational technology which is quicker, better and cheaper than current tissue sealants. It can be ubiquitously used for almost all current surgical procedures where hemostasis is required, because it seals in acid, alkaline and proteolytic environments. It breaks a barrier and is lifesaving when used in surgical procedures on patients suffering from clotting deficiencies or on blood thinners. LTW is specifically suitable when dealing with solid visceral organs with a soft friable sponge like parenchyma, such as liver, pancreas, spleen and kidney. It enables the surgeon to undertake resections in non-anatomical planes join and seal the parenchyma with minimal thermal damage. This creates a new genre or paradigm of innovative enhanced surgical capabilities for several hereto unmet clinical needs in orthopedics, dentistry, craniofacial surgery, neurosurgery, urology, oncology, plastic and trauma surgery. It is particularly well suited for minimally invasive, robotic and the advent of automated surgery.
Project Terms: Abdomen; Abdominal Abscess; Ablation; Acids; Address; Adenocarcinoma; Aftercare; Albumins; Anesthesia procedures; Animals; Anticoagulants; Anticoagulation; Arts; Bile fluid; Biocompatible Materials; Biological Preservation; biomaterial compatibility; Blood; Blood Coagulation Disorders; Body of pancreas; Body Weight; cancer transplantation; Cerebrospinal Fluid; Cessation of life; chronic pancreatitis; Clinical; Clinical Pathology; Clinical Research; Clinical Trials; Coagulation Process; Collection; commercial application; Control Groups; craniofacial; Defect; Dental; Dentistry; Development; Device Safety; Devices; Distal; Domestic Pig; Ductal; Electrolytes; Enteral; Environment; Evaluation; Excision; Extravasation; Family suidae; Female; Fistula; follow-up; gastrointestinal; Goals; Government; Grant; Head; Health; Healthcare; Hemorrhage; Hemostatic function; Histopathology; Human; Hypospadias; improved; In Vitro; in vivo; innovation; Institutional Review Boards; invention; Kidney; Label; Lasers; Lesion; Life; Liquid substance; Liver; liver repair; liver transplantation; Lymph; Malabsorption Syndromes; male; Marketing; Mediating; Methods; minimally invasive; Morbidity - disease rate; mortality; Necrosis; Nephrectomy; neurosurgery; Normal tissue morphology; novel; oncology; Operating Rooms; Operative Surgical Procedures; Organ; Orthopedics; Outcome; Pancreas; Pancreatectomy; Pancreatic Fistula; pancreatic neoplasm; Pancreaticoduodenectomy; Pancreaticojejunostomy; Patients; Perioperative; Peritonitis; Persons; Phase; Porifera; Postoperative Period; preclinical efficacy; preclinical safety; prevent; Process; prototype; public health relevance; radiofrequency; Randomized; repaired; Resected; Resources; Robotics; Safety; scaffold; seal; secondary infection; Sepsis; Septicemia; Series; Small Business Innovation Research Grant; Solid; Spinal Fusion; Spleen; Staging; standard of care; Sterility; success; Surface; Surgeon; Surgical Management; Surgical sutures; Tail; Technology; Testing; Therapeutic Effect; Thermal Ablation Therapy; Time; tissue welding; Tissues; Toxic effect; Trauma; treatment group; treatment site; tumor; Urethra; Urine; Urology; Visceral; Welding; Wound Infection
