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Published:  August 29, 2011

St. Luke’s Episcopal Hospital Conducts First Clinical Trial Of Laser Tissue Welding Technology for Liver Surgery

St. Luke’s Episcopal Hospital (St. Luke’s) is conducting the first clinical trial of a leading-edge laser technology designed to effectively weld tissue without cauterization. Designed to rapidly, accurately and effectively stop bleeding by instantly sealing tissues without cauterization, the laser tissue welding technology is being tested with high expectations of improved operative and post-operative results.

Today, surgeons lack the ability to seal the liver during surgery without burning the tissue. The liver consists of jelly-like tissue, which makes suturing a challenge.  The liver is also the largest and most commonly injured abdominal organ after blunt or penetrating trauma. And, as the central chemical processing and filter of the body, it is the most common location for metastatic cancer from other organs, especially the colon. These factors create a real and urgent medical need for improving tissue sealing of the liver and other solid visceral organs including the kidney, spleen and pancreas, which when damaged or operated on can result in morbidity and mortality. Currently, there are no surgical modalities available to repair or adequately control this type of bleeding. 

Bonding the edges of human tissue is the most vital step in most surgical procedures.  While the current closure and sealing methods in surgery today involve sutures, staples or burning tissues, these options introduce foreign materials or retain dead tissues that cause inflammation, prolong pain, recovery and increase scar tissue. 

Launched earlier this year, the Laser Tissue Welding clinical trial uses a FDA investigational device exemption (IDE) approval for this innovative initiative and has experienced positive results thus far.  Kathy Ricks, a 51 year old Houston resident, was diagnosed with colon cancer and underwent colon removal surgery in June 2010. Ricks received six chemotherapy treatments when her physician determined the cancer had metastasized to her liver. She was referred to surgeon Omar Barakat, MD at St. Luke’s Episcopal Hospital for surgical removal of the liver tumors.  Dr. Barakat offered Ricks the option to undergo a novel laser bonding surgical procedure using a laser-biologic combination device undergoing clinical trials under the direction of R. Patrick Wood, MD. Ricks enrolled in the clinical study with the Clinical Research Department at St. Luke’s and was operated on by Dr. Barakat in March 2011.

Although Dr. Barakat removed nearly one third of Rick’s liver during the procedure, the laser tissue bonding or welding to seal the liver took less than seven minutes and she received no blood transfusions or abdominal drains. Ricks was off of pain medicine the next day and released from the hospital in 72 hours.  While typically the total operation takes over four hours, her procedure was completed in one hour, and while the recovery from this major operation ranges from six to eight weeks, Rick’s returned to work in three weeks following her procedure. 

“The laser-assisted bonding procedure is an excellent option for a variety of patients, especially those undergoing liver procedures.  For those who qualify to participate in this research study, this option can significantly improve their outcome,” explains Barakat.  “As liver operations are prone to excessive bleeding, this technology holds promise in reducing the bleeding and bile leakage from the liver which is an important advancement for medicine.”

Tissue welding is performed with an 810 nanometer semiconductor diode laser and two human albumin biomaterials which function as the glue and scaffold, surgically binding tissues to stop bleeding instantly. The two human albumin bio-absorbable biomaterials were invented by Yasmin Wadia, MD.

As the clinical trail progresses at St. Luke’s, Dr. Wadia expects similar results to Ricks.  “It is my hope that this technology will bring a multitude of benefits to hospitals and surgeons by decreasing operating procedure time, removing the need for abdominal drains, reducing blood transfusions and inpatient stay. Most importantly for patients, I hope this option will reduce the pain, and allow them to return to their lives sooner rather than later.”

For more information about the clinical trial, visit www.stlukeshouston.com or contact a St. Luke’s Episcopal Hospital Research Coordinator, at ocr@sleh.com or 832-355-3710.

Disclosure: The Laser Tissue Welding device is being used in clinical trials and has not been approved by the FDA nor is it commercially available for sale.

Laser Tissue Welding, Inc. located in Humble Texas is commercializing this technology. For more information visit www.lasertissuewelding.com
 


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