Topics

Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage

2019-02-25 00:28:31 | BioPortfolio

Summary

The primary objective is to evaluate the efficacy and assess the role of Porcine Fibrin Sealant (Bioseal®) in preventing cervical anastomotic leakage after esophagectomy in the patients with resectable thoracic esophageal cancer and gastroesophageal junction cancer.

Description

Esophageal cancer (EC) is the most common cancers in the world, with more than 16,910 new cases and 15,690 deaths annually worldwide. Every year in China, no matter new cases or deaths account for more than half of the world. Currently, surgery is the most important and effective treatment for esophageal cancer. According to the recommendation in Chinese Experts' Consensus on Esophageal Cancer Radical Surgery (year 2017), the rightapproach esophagectomy should be adopted, in order to achieve radical lymph nodes dissection and improve the surgical outcomes. So Mckeown procedure is recommended preferentially. However, esophageal resection for cancer has been associated perioperative mortality. One of the major perioperative complications that affect morbidity and mortality in these patients is esophageal anastomotic leakage. Moreover, it was reported that the leakage incidence of cervical anastomosis after esophageal cancer resection was significantly higher than that of intrathoracic anastomosis. Therefore, how to minimize the incidence of esophageal anastomotic leaks in esophagectomy is particularly important, especially for Mckeown surgery.

In recent years, the prognostic outcome of esophageal cancer has been improved due to advances in surgical technique. However, esophageal anastomotic leakage is still one of the most serious complications following esophagectomy, with an incidence around 5% to 40%. For example, a research based on Japanese national database showed that the rate of anastomotic leakage after esophagectomy was 13.3%. A recent phase 3 clinical trial, the ChemoRadiotherapy for Oesophageal Cancer Followed by Surgery Study (CROSS) reported an anastomotic leak rate of 26.1% after esophagectomy. Meanwhile, data from the investigator's center indicated that the leakage rate after esophagectomy was around 21.0%. Furthermore, anastomotic leakage following esophagectomy could seriously increase early mortality. According to the previous study, the risk of perioperative 90-day death was three times in patients with anastomotic leakage after esophagectomy than those without leaks (18.2% vs. 6.2%, P=0.003), and hospitalization was significantly increased.

Bioseal® (Guangzhou Bioseal Biotech Co., Ltd., China) is a porcine-derived fibrin sealant that has been widely used in various surgical procedures to assist in hemostasis for more than a decade. This type of fibrin sealant is made from biologically porcine-derived thrombin and fibrinogen, and is designed to form a stable fibrin clot by simulating the final pathway of the coagulation cascade. The fibrin clot will form a gel-like material on the surface of the surgical wound, which can not only directly block the tissue defect, but also promote the healing of the wound by using the fibrin network as the matrix where the fibroblasts and capillary endothelial cells can proliferate to form granulation. Therefore, Bioseal® have been reported to be used as sealing agent as well as wound healing agent during surgery in some studies.

In the recent years, some investigators have attempted to use the fibrin sealant to treat or prevent gastrointestinal leakage after enterectomy, gastrectomy, esophagectomy, or pancreaticoduodenectomy. The preliminary results show application of fibrin sealant may lower the chances of anastomotic leakage. Hence, it can diminish the mortality and morbidity of those patients with gastrointestinal reconstructions.

In 2004, a study conducted by Nguyen both in vitro and in vivo, found that application of fibrin sealant over gastric bypass could reduce the postoperative anastomotic leakage. Among the 16 animals (pigs) undergoing laparoscopic gastric bypass, 10 cases were applied with fibrin sealant on their primary anastomosis, and no anastomotic leakage or related complications was found. Five of the other 6 cases in control group had fistula or intra-abdominal abscess. Moreover#the follow-up study in humans showed that 66 patients in whom fibrin sealant was used as reinforcement on a primary anastomosis were all free of anastomotic leakage. In China, some studies also reported fibrin sealant could prevent anastomotic leakage for patients undergoing resection of rectal carcinoma or pancreato-biliary tumors.

As to esophagectomy, only few pilot studies have reported the similar attempts to prevent anastomotic leakage by using fibrin sealant. In 2007, Ling reported that application of fibrin sealant while implanting an esophageal stent under endoscopy was an effective approach for treating the postoperative esophageal anastomotic leakage. The studies conducted by Celal also showed that endoscopic treatment combined with fibrin sealant could be considered as a valuable option for the management of postoperative esophageal anastomotic leakage with a high degree of technical feasibility and safety. However, studies focusing on the role of fibrin sealant in the prevention of cervical leakage after esophagectomy are few.

In 2007, a prospective clinical trial conducted by Upadhyaya enrolled 45 infant patients who underwent esophagectomy for congenital esophageal atresia (EA) with tracheoesophageal fistula (TEF). In that study, a total of 52 patients were divided into two groups. In Group A, patients received fibrin sealant as reinforcement on a primary end-to-end esophageal anastomosis. In group B, fibrin glue was not used. In the final analysis, the overall rate of postoperative leakage is 26.9% (12/45), including 9.1% (2/22) in group A and 43% (10/23) in group B (p=0.017). In 2009, Saldaña-Cortés conducted a similar research but on puerile esophagectomy for caustic injury. Results showed that the postoperative cervical anastomotic dehiscence and leakage were observed in 28.5% of patients who received fibrin sealant in the study group and 50% of those in the control group. Both of those two studies indicated that fibrin glue, when used as a sealant for cervical esophageal anastomosis, could reduce the risk of leakage.

However, there is still no large-scale clinical trial investigating the use of fibrin sealant to prevent cervical anastomotic leakage after esophagectomy for esophageal cancer all over the world. The purpose of this study is to assess the role of fibrin glue (Bioseal®) in the prevention of leakage at the cervical esophageal anastomosis for esophageal cancer patients undergoing Mckeown surgery.

Study Design

Conditions

Esophageal Anastomotic Leak

Intervention

Porcine Fibrin Sealant (PFS), McKeown esophagectomy

Location

Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
China
510060

Status

Recruiting

Source

Sun Yat-sen University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-02-25T00:28:31-0500

Clinical Trials [1275 Associated Clinical Trials listed on BioPortfolio]

Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage After Esophagectomy for Esophageal Carcinoma.

The primary objective is to evaluate the efficacy and assess the role of Porcine Fibrin Sealant (Bioseal®) in preventing cervical anastomotic leakage after esophagectomy in the patients w...

Fibrin Sealant in Esophageal Surgery

Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. ...

A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimall...

Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices

The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding esop...

Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection

Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tu...

PubMed Articles [1522 Associated PubMed Articles listed on BioPortfolio]

Ultrathin endoscopy versus computed tomography in the detection of anastomotic leak in the early period after esophagectomy.

Anastomotic leak after esophagectomy is a major postoperative complication that leads to significant mortality. The aim of this study was to evaluate the safety of early postoperative ultrathin endosc...

Coniform gastric tube for end-to-end anastomosis during minimally invasive McKeown esophagectomy.

For McKeown esophagectomy, gastric tube is widely used for constructing esophagogastrotomy. Traditionally, the gastric fundus is preserved for gastric tube formation in order to provide adequate lengt...

The economic burden of endoscopic treatment for anastomotic leaks following oncological Ivor Lewis esophagectomy.

Complications after surgery for esophageal cancer are associated with significant resource utilization. The aim of this study was to analyze the economic burden of two frequently used endoscopic treat...

Modified Blood Patch Used to Treat a High Output Chyle Leak after McKeown Esophagectomy.

Chyle leaks after esophagectomy are associated with significant morbidity and mortality. High output fistulas are particularly difficult to manage, as the likelihood of spontaneous closure with conser...

Routine Esophagram for Detecting Anastomotic Leak After Esophagectomy.

Medical and Biotech [MESH] Definitions

Infection within the PERITONEAL CAVITY. A frequent cause is an ANASTOMOTIC LEAK following surgery.

Breakdown of the connection and subsequent leakage of digestive system fluid from a SURGICAL ANASTOMOSIS of digestive system structures. Most common leakages are from breakdown of the sutured lines in gastrointestinal or bowel anastomosis.

Species of ENTEROVIRUS causing mild to severe neurological diseases among pigs especially in Eastern Europe. Mild strains are also present in Canada, U.S., and Australia. Specific species include Porcine enterovirus A and Porcine enterovirus B.

A condition characterized by recurring episodes of fluid leaking from capillaries into extra-vascular compartments causing hematocrit to rise precipitously. If not treated, generalized vascular leak can lead to generalized EDEMA; SHOCK; cardiovascular collapse; and MULTIPLE ORGAN FAILURE.

A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.

More From BioPortfolio on "Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage"

Quick Search

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial