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Trial record 25 of 49 for:    Zollinger-Ellison syndrome

Laser Tissue Welding - Distal Pancreatectomy Sealing Study (LTW)

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ClinicalTrials.gov Identifier: NCT03147768
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
CHI St. Luke's Health, Texas
Information provided by (Responsible Party):
Laser Tissue Welding, Inc.

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.


Condition or disease Intervention/treatment Phase
Pancreatic Tumor, Benign Pancreatic Neoplasms Pancreatic Adenocarcinoma Pancreatic Pseudocyst Pancreatic Neuroendocrine Tumor Pancreas; Insulinoma Pancreatic Cyst Pancreatic Teratoma Pancreatic Polypeptide Tumor Pancreatic Vipoma Pancreatic Cystadenoma Pancreas Injury Pancreatic Gastrinoma Pancreatic Glucagonoma Device: Distal Pancreatectomy Sealing Using LTW Phase 1

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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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label Combination Product (Laser + Biologic + Drug) regulated as a device
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Phase I Feasibility Trial To Study The Safety Of Sealing Resected Pancreatic Surfaces After Partial Distal Pancreatectomy Using Laser Tissue Welding
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 1, 2020


Arm Intervention/treatment
Experimental: Distal Pancreatectomy Sealing using LTW
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.
Device: Distal Pancreatectomy Sealing Using LTW
The device's intended use is to seal the pancreatic surface using a laser to weld human albumin based biomaterials after surgical removal of pancreatic tumors during a partial pancreatectomy.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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.

  3. SECONDARY SAFETY: Surgical space abscess [ Time Frame: 30 days ]
    Secondary infection, intra-abdominal abscess formation requiring surgical evacuation


Other Outcome Measures:
  1. SECONDARY EFFICACY: Total operating time (minutes) [ Time Frame: Intra-operative assessment ]
    Duration and Cost Metric

  2. SECONDARY EFFICACY: Pancreas clamp time (minutes) [ Time Frame: Intra-operative assessment ]
    Duration Metric: Assesses organ ischemia and handling, and will correlate with compromised function (rise in serum Amylase and Lipase) (assesses organ ischemia and will correlate with compromised function)

  3. SECONDARY EFFICACY: Laser tissue welding time or time to hemostasis (Duration Metric) [ Time Frame: Intra-operative assessment ]
    Duration and Cost Metric

  4. SECONDARY EFFICACY: Length of ICU stays (Duration and cost Metric ) [ Time Frame: 30 days ]
    Duration and Cost Metric

  5. SECONDARY EFFICACY: Total hospital stay (Duration and cost Metric ) [ Time Frame: 3 months ]
    Duration and Cost Metric



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147768


Contacts
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Contact: OMAR BARAKAT, M.D. 713-798-2262 omar.barakat@bcm.edu
Contact: BRIDGET SOLIS 713-798-1037 bsolis@bcm.edu

Locations
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United States, Texas
Baylor CHI St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Aline Barzilla    713-798-6230    barzilla@bcm.edu   
Contact: Bridget Solis    713-798-1037    bsolis@bcm.edu   
Principal Investigator: OMAR BARAKAT, M.D.         
Sponsors and Collaborators
Laser Tissue Welding, Inc.
National Cancer Institute (NCI)
CHI St. Luke's Health, Texas
Investigators
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Principal Investigator: OMAR BARAKAT, M.D Baylor CHI St. Luke's Medical Center, Houston, Texas
Study Director: STEPHEN HAROLD, M.D.; MPH; CCRC Baylor CHI St. Luke's Medical Center, Houston, Texas

Additional Information:
Publications:
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Responsible Party: Laser Tissue Welding, Inc.
ClinicalTrials.gov Identifier: NCT03147768     History of Changes
Other Study ID Numbers: Phase I - LTW Pancreas Sealing
R44CA203052 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Laser Tissue Welding, Inc.:
Laser Tissue Welding
Pancreatic Sealing
Hemostasis
Pancreatic Tumors
Pancreatic Resection
Pancreatic leakage
LTW
Additional relevant MeSH terms:
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Gastrinoma
Neuroendocrine Tumors
Teratoma
Pancreatic Neoplasms
Pancreatic Cyst
Insulinoma
Pancreatic Pseudocyst
Glucagonoma
Cystadenoma
Vipoma
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenoma, Islet Cell
Adenoma
Cysts
Carcinoma, Islet Cell
Neoplasms, Cystic, Mucinous, and Serous
Carcinoma, Neuroendocrine