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Laser Tissue Welding - Distal Pancreatectomy Sealing Study

Trial Status: Complete

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.

Inclusion 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.

Texas

Houston
Baylor Saint Luke's Medical Center
Status: WITHDRAWN
Contact: Bridget Solis
Phone: 713-798-1037

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.

Trial Phase Phase I

Trial Type Device

Lead Organization
Laser Tissue Welding, Inc.

  • Primary ID Phase I - LTW Pancreas Sealing
  • Secondary IDs NCI-2019-05520, R44CA203052
  • Clinicaltrials.gov ID NCT03147768