Laser Tissue Welding – Distal Pancreatectomy Sealing Study

Brief Title

Laser Tissue Welding - Distal Pancreatectomy Sealing Study

Official Title

Phase I Feasibility Trial To Study The Safety Of Sealing Resected Pancreatic Surfaces After Partial Distal Pancreatectomy Using Laser Tissue Welding

Brief 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.
    

Detailed Description

      UNMET CLINICAL NEED

      In the United States, pancreatic cancer is the fourth leading cause of cancer-related death
      in both men and women and will be the second leading case by 2030. Pancreatoduodenectomy
      (Whipple procedure) and distal partial pancreatectomy is used to treat pancreatic tumors, and
      these procedures are associated with a high rate of morbidity due to pancreatic fistulae.

      As per the Surveillance, Epidemiology and End Results (SEER) Program: It is estimated that
      41,609 men and women (21,370 men and 21,770 women) will be diagnosed with and 38,460 men and
      women will die of cancer of the pancreas in 2013. The five-year survival is dismal, 24.1% for
      localized malignancy, and drops to 6% if there is regional spread. There are 45,220 new cases
      in 2013 and 38,460 deaths.

      Distal Pancreatectomy may be indicated for malignant exocrine tumors of the body and tail of
      pancreas (62%), insulinomas, chronic pancreatitis (12%), pancreatic pseudocysts, non
      pancreatic tumors (23%) and injury due to trauma.

      Due to heighten awareness and preventative care, there has been an increase in detection of
      incidental small pancreatic mass cases due to widespread use of abdominal cross sectional
      imaging and thus an increase in the amount of pancreatic surgery performed. This is the stage
      when curative resections may be possible.

        1. Surgical removal of the tumor is the only chance of a cure at T1A.

        2. All pancreatic tumors at any stage require bulk reduction by a surgical procedure.

      For patients undergoing distal pancreatectomy, pancreatic fistulas occurred post-operatively
      in 31% of patients. Over the long-term Kazanjian et al 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. Pancreatic fistula
      is a main cause of postoperative morbidity, and is associated with numerous further
      complications, such as intra-abdominal abscesses, wound infection, sepsis, electrolyte
      imbalance, malabsorption, and hemorrhage, and with a dramatically increase in healthcare
      resource utilization.

      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.

        -  Endo GIA Staplers: 510 (k) k111825 Cleared on basis of "literature review" without
           animal or human safety or efficacy data.

        -  Gore SeamGuard staple/suture reinforcement material 510 (k) k043056 Synthetic bio
           absorbable glycolide and trimethylene carbonate copolymer. Cleared on basis of in-vivo
           studies done "without performance standards" under section 514.

        -  Surgical Sealants: All used "off label": None are FDA cleared or approved for pancreatic
           surgery. These are Floseal, TachoSil, Tisseel, BioGlue, and CoSeal.

      Jörg Kleeff et al reviewed the factors for surgical failure of distal pancreatectomy in 302
      consecutive patients from 1993 to 2006 using four different surgical closures (gut
      anastomosis, seromuscular patch, suture and stapling device). Although distal pancreatectomy
      is less moribund as compared to Whipple procedure, morbidity was 32-52%, pancreatic fistulas
      occurred in 20-33% and mortality in 2% of cases. Pancreatic fistulas contributed
      significantly to morbidity, sepsis, length of stay and overall costs. Stapler closure of the
      pancreatic remnant is associated with a significantly higher fistula rate.

      Laser Tissue Welding is the first combination (laser and biologic) class III surgical device
      intended to join and seal tissues accurately and instantly. The treatment process uses
      thermal energy created when a laser excites photosensitive dye molecules, to coagulate the
      protein albumin which transforms from a liquid to a solid instantly. Laser tissue welding
      creates a non-compressive, non-ablative sealing of tissues with microscopic thermal damage.
      This combination of a laser with albumin biologics stops bleeding and fluid leaks in
      nanoseconds without using sutures, hemostatic clotting factors (platelets/thrombin/fibrin),
      thermal or cryoablation.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

PRIMARY EFFICACY AS A SEALANT: Intra-operative blood loss

Secondary Outcome

 SECONDARY SAFETY: Post-operative blood loss requiring return to the operating room

Condition

Pancreatic Tumor, Benign

Intervention

Distal Pancreatectomy Sealing Using LTW

Study Arms / Comparison Groups

 Distal Pancreatectomy Sealing using LTW
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

January 1, 2018

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

        Eligible participants will be 18 years and older of both genders.

          1. 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.

          2. Serum creatinine: ≤ 2.5 mg/dL

          3. Glomerular filtration rate greater than ≥ 50 ml/min/m2

          4. Platelet count ≥ 50,000/mm3

          5. Prothrombin time < 18 seconds

          6. PTT not >1.5 times control (except for therapeutically; anticoagulated nonrelated
             medical conditions [e.g., atrial fibrillation]);

          7. Serum albumin levels > 3g/dL (Normal range 3.5 to 5 g/dL)

        Exclusion Criteria:

          1. Age younger than 18 years' old

          2. Severe uncorrected hypertension (> 180 systolic and >110 diastolic)

          3. Uncorrectable coagulopathies (on Plavix, Aspirin or Lovanox)

          4. Pregnancy

          5. Females who are breast feeding who do not switch the infant to formula prior to
             surgery

          6. Active urinary tract infection

          7. T1b (>4 cm) lesion and above

          8. Systemic or local infection.

          9. Subject has known allergy or intolerance to iodine or human serum albumin.

         10. Recent febrile illness that precludes or delays participation preoperatively.

         11. Treatment with another investigational drug or other intervention during the study and
             follow-up period.

         12. Anything that would place the individual at increased risk or preclude the
             individual's full compliance with or completion of the study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

OMAR BARAKAT, M.D, 713-798-2262, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03147768

Organization ID

Phase I - LTW Pancreas Sealing

Secondary IDs

R44CA203052

Responsible Party

Sponsor

Study Sponsor

Laser Tissue Welding, Inc.

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

OMAR BARAKAT, M.D, Principal Investigator, Baylor CHI St. Luke's Medical Center, Houston, Texas


Verification Date

September 2020