Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

Coagulants

All Drugs and Chemicals

Hemostatics

The laser tissue welding device is intended for use in patients requiring laparoscopic surgery requiring hemostasis and sealing of the resected kidney after partial nephrectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure.

The device's intended use is to seal the kidney surface using a laser to weld human albumin based biomaterials after surgical removal of kidney tumors during a laparoscopic partial nephrectomy.

Laparoscopic partial nephrectomy will be robotically assisted using the second generation da Vinci® Surgical System. Once the tumor is resected with laparoscopic scissors with a margin of healthy tissue, the solder will be dripped onto the cut surface of the parenchyma. A laparoscopic rigid 5mm spot-size laser hand-piece will be passed through the 10-mm port. The diode laser will be then used to weld a thin layer of solder onto the cut parenchymal surface. The 60 Watt 810-nm diode laser will be set to deliver continuous energy. During soldering, the tip of the laparoscopic laser hand-piece will be maintained 1 to 2 cm from the renal surface to generate a spot size of approximately 5 mm. Each spot will be treated with the laser until the color of the solder changes from green to white. The renal pedicle clamp will be removed to allow renal blood supply to be restored and the surgical site inspected for evidence of bleeding for 10 minutes prior to completing the surgical procedure.

Laser Tissue Welding Device

RICHARD LINK, M.D.

The objective of this pilot study will be to obtain a clinical safety and efficacy endpoint profile of laser tissue welding therapy for sealing the resected kidney surface after laparoscopic partial nephrectomy required for removal of resectable benign or malignant renal tumors in 10 patients.

SCIENTIFIC RATIONALE:

The use of partial nephrectomy to treat small newly diagnosed kidney tumors is vastly under-used as per NCI statistics (http://www.cancer.gov/cancertopics/treatment/partial-nephrectomy0208).

As per the Surveillance, Epidemiology and End Results (SEER) Program, (http://seer.cancer.gov/statfacts/html/kidrp.html), the prevalence of cancer of the kidney and renal pelvis is 296,074 while the estimated new cases are 46,410 and deaths 13,040 in the United States in 2010 (www.cancer.gov/cancertopics/types/kidney).

There has been an increase in detection of incidental small renal mass (≤ 4cm) cases (TNM staging T1a) due to widespread use of ultrasound and abdominal cross sectional imaging (CT, MRI) and thus an increase in the amount of renal surgery performed. Current surgical practice for nephron sparing surgery allows at least 1 cm margin of normal tissue around the tumor3. This is the stage when curative resections are possible.

During a partial nephrectomy, the renal artery is clamped to minimize bleeding while resecting the tumor. Since a major reconstruction is required with suturing, clamp time can be significant, anywhere between 15 and 45 minutes. It has been repeatedly shown that reducing clamp time preserves renal function and that there is significant damage to the kidney if the renal artery is clamped for more than 30 minutes. This is especially crucial when dealing with patients with hypertension, diabetes, chronic renal failure or a tumor in a single kidney. Extended clamp time can result in decreased renal function and ultimately the need for dialysis at some point. Because of the inherent difficulties of laparoscopic suturing, this has not been widely used particularly in view of the risk of prolonged warm ischemia time. Many patients therefore undergo a radical nephrectomy instead of a nephron sparing procedure. Hemorrhage 9.5% (1) , is the major complication following partial nephrectomy. Besides bleeding (1) urinary fistula (4.5%), ureteral obstruction, and renal insufficiency due to prolonged warm ischemia times are further complications of partial nephrectomy.

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. (Video: http://www.lasertissuewelding.com/application.aspx?AID=8)

First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy

Phase-I Feasibility Trial To Study The Safety Of Laser Tissue Welding For Sealing Resected Kidney Surfaces After Laparoscopic Partial Nephrectomy

Observed intra-operatively. Assesses organ ischemia time and will correlate with compromised renal function post-surgery.

Observed intra-operatively:

Cumulative time to complete hemostasis. This will be compared to current standard of care time-to-hemostasis using suture closure which is anywhere between 15 and 45 minutes since a major renal reconstruction is required with suturing and therefore correlated to significant clamp time, renal ischemia and renal dysfunction.

Number of days spent in intensive care unit (ICU).

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 assessment of the blood loss: Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemo-dilution. Therefore is correlated with blood products transfused to compensate for the blood lost during surgery.

Clinical assessment of the blood loss:

1. Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemodilution. Therefore is correlated with blood products transfused to compensate for the blood lost post-operatively.
2. Correlated to post-operative JP tube drainage, amount and type.

Post-operative blood loss requiring return to the operating room

Urinary 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 kidney (blood or urine) will be assessed with U/S and CT scan at the mentioned time points.

To see if the protein solder is a nidus for stone formation

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Laser Tissue Welding, Inc.

Symptoms and General Pathology

Digestive System Diseases

Hemorrhage

Neoplasm Metastasis

Liver Neoplasms

Blood Loss, Surgical

Intraoperative Complications

Hematinics

Liver Extracts

Mario Serradilla Martin, MD, FACS

Serradilla-Martin Mario, MD, FACS

Surgical hemostasis has become one of the fundamental principles for the advancement of surgery. The use of hemostatic agents is standard in many surgical specialties, although the lack of consensus or standardized classifications to determine intraoperative bleeding has led to their inappropriate selection on many occasions. The recommendations of international organizations highlight the need for a bleeding severity scale validated in clinical studies that allows selecting the hemostatic agent that best suits each case.

Surgical hemostasis has become one of the fundamental principles for the advancement of surgery. The use of hemostatic agents is standard in many surgical specialties, with greater use in major surgeries. Inadequate hemostasis significantly increases the risk of perioperative morbidity and mortality, healthcare costs and the use of resources. The need for hemostasis has led to the development of various topical hemostatic agents.

Clinical studies that have analyzed the use of topical hemostats have not used standardized definitions or classifications to determine the severity of intraoperative bleeding, partly due to a lack of consensus on the definition of the severity of bleeding and partly due to the severity of bleeding. lack of requirements to do so. This has led many surgeons to an inadequate selection of hemostats for different bleeding situations, the results being inefficient. Using standardized criteria, the results of clinical studies can be compared to determine the effectiveness of hemostatic agents.

The FDA (Food and Drug Administration) requires the use of a bleeding severity scale validated in clinical studies investigating hemostatic agents. The VIBe (Validated Intraoperative Bleeding Scale) for intraoperative bleeding was developed in 2017.This scale has been validated by a large number of expert surgeons from all specialties, but in an animal model. However, it has not yet been clinically validated.

Liver surgery is one of the surgeries where intraoperative bleeding is more important. In Spain, around 5000 liver resections are performed annually, not including liver transplants. It is, therefore, a perfect framework to validate the applicability of the VIBe scale of severity of intraoperative bleeding.

In order to evaluate the viability of a prospective clinical study in liver surgery, a parallel project has been worked on based on the evaluation of the applicability of the VIBe scale, carried out by liver surgeons by reviewing the original video recordings described in the VIBe scale. Forty-seven surgeons were selected from 10 medium-high-volume liver surgery centers, all of them reference centers (same centers that will participate in the prospective study). 5 of the 10 hospitals perform liver transplants. These centers have a mean reference population of 922,506 ± 225,603 patients. The mean number of major hepatectomies per year is 23 ± 16, the number of minor hepatectomies 56 ± 24, and the number of liver transplants 40 ± 27. 40.5% of all hepatectomies are performed by a minimally invasive approach.

The 47 surgeons viewed 14 videos used by Lewis et al. for the validation of the original VIBe scale. 63.3% of the participating surgeons were men with a mean age of 41.6 years. 17% were unit / department heads and 83% were senior surgeons. The mean experience was 9.3 years, and the majority were experts (21.3%) or with advanced knowledge (53.2%) in minimally invasive surgery. Only 23.4% had prior knowledge of the VIBe scale, but all surgeons used hemostats in their daily clinical practice. The VIBe scale achieved a mean intraobserver agreement of 0.985 and an interobserver agreement of 0.929, neither of which was influenced by the experience of the surgeon or the volume of surgeries per year. The average rating for all videos was 67% correct, in line with the original validation. Most surgeons considered that the scale represented the range of severity of bleeding in their procedures (91%), relevant to assess intraoperative hemostasis in clinical studies (96%) and clinical practice (87.2%), useful in CMI (96%), and also to differentiate hemostatic agents (81%).

With these preliminary data, based on the video classification exercise, we can conclude that the VIBe scale is useful for the assessment of the severity of bleeding performed by liver surgeons. Therefore, an assessment of the severity of intraoperative bleeding using the scale in actual liver surgery is feasible. Our goal is to publish these results independently before starting the clinical observation record.

To evaluate the clinical applicability, a prospective registry of patients undergoing liver surgery has been designed in the 10 selected Spanish centers. Demographic and preoperative, intraoperative and postoperative data will be collected. Intraoperative bleeding will be measured according to the VIBe scale at two points of the surgical intervention: the maximum bleeding and at the end of the surgery. Data will be collected on the type of hemostatic or surgical strategy that has been carried out to correct bleeding (i.e. pressure, suture, coagulation, hemostatic, etc.) and other data related to bleeding (blood loss, units of blood transfused, etc.). Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Major complications are defined as those with a Clavien-Dindo ≥ IIIa. The classification of liver failure and postoperative bleeding are defined following the International Study Group of Liver Liver Surgery (ISGLS) classifications. At the end of the registration a statistical analysis of the data will be performed to determine the applicability and usefulness of the VIBe scale in liver surgery, as well as to determine the relationship between the type of bleeding, the hemostatic measurements used, the success rate of the hemostatic measurements, and the bleeding-related complications.

Despite the extensive literature published on liver surgery, there is no scientific evidence that allows us to have validated scalds that quantify the severity of intraoperative bleeding and, consequently, select which is the best hemostatic procedure that is adapted to each case. All of this has repercussions on patient safety, increased postoperative morbidity and mortality, as well as the inappropriate use of healthcare resources and consequently increased costs.

This prospective multicenter study in national centers that perform Liver Surgery aims to evaluate and validate a scale that allows quantifying intraoperative bleeding in liver surgery.

VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER SURGERY

VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER SURGERY. PROSPECTIVE AND MULTICENTRIC STUDY

To validate the VIBe scale for intraoperative bleeding in liver surgery.

Assess the repeatability, reproducibility and usefulness of the scale in this type of surgery.

Determine the relationship between type of bleeding and hemostatic used, the success rate of hemostatic measurements, and complications related to bleeding.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy	NCT02061605	Benign Renal Tu... Malignant Renal...	Laser Tissue We...	18 Years -	Laser Tissue Welding, Inc.
VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER SURGERY	NCT05369988	Surgical Hemorr... Liver Cancer Liver Metastase...		18 Years -	Hospital Miguel Servet

Spots Global Cancer Trial Database for surgical hemostasis