Clinical Trial: Laser Tissue Welding - Distal Pancreatectomy Sealing Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

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%
Sponsor: Laser Tissue Welding, Inc.

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Laser Tissue Welding, Inc.

Dates:
Date Received: May 8, 2017
Date Started: May 15, 2017
Date Completion: June 2019
Last Updated: May 9, 2017
Last Verified: May 2017