Laser Tissue Welding - Distal Pancreatectomy Sealing Study

NCT03147768 | Completed Phase 1 DMC FDA Device

• 2 other identifiers: Phase I - LTW Pancreas SealingR44CA203052
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Laser Tissue Welding; Pancreatic Sealing; Hemostasis; Pancreatic Tumors; Pancreatic Resection; Pancreatic leakage; LTW

Outcome Measures

Primary Outcomes (1)

• PRIMARY EFFICACY AS A SEALANT: Intra-operative blood loss

  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.

  Intra-operative

Secondary Outcomes (3)

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

  30 days

• SECONDARY SAFETY: Prolonged post-operative pancreatic leakage

  30 days

• SECONDARY SAFETY: Surgical space abscess

  30 days

Other Outcomes (5)

• SECONDARY EFFICACY: Total operating time (minutes)

  Intra-operative assessment

• SECONDARY EFFICACY: Pancreas clamp time (minutes)

  Intra-operative assessment

• SECONDARY EFFICACY: Laser tissue welding time or time to hemostasis (Duration Metric)

  Intra-operative assessment

Study Arms (1)

Distal Pancreatectomy Sealing using LTW

EXPERIMENTAL

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

Interventions

Distal Pancreatectomy Sealing Using LTW DEVICE

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.

Distal Pancreatectomy Sealing using LTW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be 18 years and older of both genders.
• 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.
• Serum creatinine: ≤ 2.5 mg/dL
• Glomerular filtration rate greater than ≥ 50 ml/min/m2
• Platelet count ≥ 50,000/mm3
• Prothrombin time \< 18 seconds
• PTT not \>1.5 times control (except for therapeutically; anticoagulated nonrelated medical conditions \[e.g., atrial fibrillation\]);
• Serum albumin levels \> 3g/dL (Normal range 3.5 to 5 g/dL)

You may not qualify if:

• Age younger than 18 years' old
• Severe uncorrected hypertension (\> 180 systolic and \>110 diastolic)
• Uncorrectable coagulopathies (on Plavix, Aspirin or Lovanox)
• Pregnancy
• Females who are breast feeding who do not switch the infant to formula prior to surgery
• Active urinary tract infection
• T1b (\>4 cm) lesion and above
• Systemic or local infection.
• Subject has known allergy or intolerance to iodine or human serum albumin.
• Recent febrile illness that precludes or delays participation preoperatively.
• Treatment with another investigational drug or other intervention during the study and follow-up period.
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Sponsors & Collaborators

• Laser Tissue Welding, Inc.: lead
• National Cancer Institute (NCI): collaborator
• CHI St. Luke's Health, Texas: collaborator

Study Sites (1)

Baylor CHI St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (4)

• Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb.

  PMID: 17414606 BACKGROUND

• Goh BK. Re: Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2008 Feb;247(2):392-3; author reply 393. doi: 10.1097/SLA.0b013e318164022d. No abstract available.

  PMID: 18216551 BACKGROUND

• Kazanjian KK, Hines OJ, Duffy JP, Yoon DY, Cortina G, Reber HA. Improved survival following pancreaticoduodenectomy to treat adenocarcinoma of the pancreas: the influence of operative blood loss. Arch Surg. 2008 Dec;143(12):1166-71. doi: 10.1001/archsurg.143.12.1166.

  PMID: 19075167 BACKGROUND

• Shrikhande SV, D'Souza MA. Pancreatic fistula after pancreatectomy: evolving definitions, preventive strategies and modern management. World J Gastroenterol. 2008 Oct 14;14(38):5789-96. doi: 10.3748/wjg.14.5789.

  PMID: 18855976 BACKGROUND

Related Links

• NCI SEERS Register Cancer Stat Facts: Pancreas Cancer
• NCI: A Snapshot of Pancreatic Cancer - Incidence and Mortality
• Endo GIA Staplers: 510 (k) k111825
• Gore SeamGuard staple/suture reinforcement material 510 (k) k043056

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Pseudocyst; Adenoma, Islet Cell; Insulinoma; Pancreatic Cyst; Vipoma; Glucagonoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Adenocarcinoma; Carcinoma; Carcinoma, Islet Cell

Study Officials

• OMAR BARAKAT, M.D

  Baylor CHI St. Luke's Medical Center, Houston, Texas

  PRINCIPAL INVESTIGATOR

• STEPHEN HAROLD, M.D.; MPH; CCRC

  Baylor CHI St. Luke's Medical Center, Houston, Texas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Combination Product (Laser + Biologic + Drug) regulated as a device

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)