Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula

Randomized Controlled Trial for Comparison of the Effects of Preventing Postoperative Pancreatic Fistula by With Versus Without TissuePatchTM Cover the Wound Surface of Pancreatic Capsule

Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. TissePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent leakage of air, blood, and fluid during neurosurgery, spine, chest, and soft tissue surgery. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Other: Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface; Other: Radical gastrectomy +D2 lymphadenectomy

Detailed Description

Gastric cancer is the fifth most common tumor and the fourth most deadly cancer disease in the world. Surgical resection is the recommended method to cure gastric cancer. In recent years, with the continuous promotion of D2 radical gastrectomy and the rapid development of new technologies such as laparoscopic and robotic surgical systems, although the incidence of complications such as abdominal bleeding, anastomotic leakage and abdominal infection has decreased, but the incidence of Postoperative pancreatic fistula is increasing. Postoperative pancreatic fistula involves the delivery of any measurable volume of fluid through surgically placed drainage tubes, and amylase activity is 3 times higher than the upper limit of normal plasma value. According to the severity of postoperative pancreatic fistula, there are three grades: A, B and C. Grade A pancreatic fistula is mainly biochemical leak (BL), not pancreatic fistula in the real sense. Grade B pancreatic fistula requires a definite change in postoperative treatment strategy, which affects the postoperative process. Continuous drainage of drainage tube in situ for > 3 weeks, or percutaneous or subultrasonic drainage is required; Grade C pancreatic fistula refers to the situation of secondary surgery, single or multiple organ failure (especially respiratory, cardiac and renal insufficiency) and even death caused by postoperative pancreatic fistula. The risk factors of pancreatic fistula after radical gastrectomy for gastric cancer mainly include: 1. Surgical methods and instrument-related factors, such as the scope of surgical resection and lymph node dissection; 2. Pancreatic factors, soft pancreas showed less fibrous tissue, inflammatory cells infiltrating pancreatic tissue and pancreatic edema, and pancreatic fistula was more likely to occur during surgery; 3. Basic information of the patient: obesity is an important risk factor for pancreatic fistula. Currently, laparoscopic surgery has been widely carried out in gastric cancer, but due to the characteristics of laparoscopic surgery and the difference in operator experience, the incidence of postoperative pancreatic fistula is higher than that of open surgery. Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. Due to the digestion of pancreatic fluid, severe pancreatic fistula is often followed by abdominal infection, postoperative bleeding, anastomotic fistula and other serious complications, even life-threatening. Therefore, the prevention and early detection of pancreatic fistula after radical gastrectomy of gastric cancer is very important. At present, there are few studies on the prevention of pancreatic fistula after gastric cancer surgery at home and abroad. The main preventive surgeries require surgeons to perform fine operations and also require individual drainage methods. These methods can reduce the occurrence of pancreatic fistula after gastric cancer surgery to a certain extent, but have weak preventive effect on the large scope of lymph node dissection. TissuePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent air, blood, and fluid leakage during neurosurgery, spine, chest, and soft tissue surgery. It is a pre-formed patch with built-in adhesive strength. It also incorporates TissuebondTM, a bio-bonding polymer that forms strong covalent bonds to protein-rich tissue surfaces. Adhesion is achieved when the prefabricated membrane is applied to the tissue bed with moderate pressure of 60 seconds, which allows contact adhesion and eliminates potential tissue space. Studies have shown that the use of TissuePatchTM in major neck surgery can effectively prevent the occurrence of chylous leakage and promote the recovery of patients. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients. Therefore, based on our experience and foundation in the treatment of gastric cancer in gastrointestinal surgery, the real world observation and research on the experimental treatment plan for the prevention of pancreatic fistula in gastric cancer patients after surgery will be carried out, and the integration of domestic superior resources will surely further promote the development of the prevention of pancreatic fistula after radical gastrectomy for gastric cancer.

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xiaohua Li, MD,PH.D; Phone Number: +8613474299901; Email: xjyylixiaohua@163.com
• Study Contact Backup: Name: zhenchang Mo; Phone Number: +8618229712293; Email: mzc131208@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Disease
      • Contact: xiaohua li, MD, PH.D; Phone Number: 13474299901; Email: lixiaohua1982@fmmu.edu.cn
      • Sub-Investigator: chao yue
      • Sub-Investigator: ruiqi gao
      • Sub-Investigator: weidong wang
      • Contact: zhenchang mo; Phone Number: 18229712293; Email: mzc131208@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histological confirmation of gastric adenocarcinoma
• Stage cT1-4a, N0-3, M0 (according to the 8th AJCC TNM staging system)
• For locally advanced tumors (cT3-4aN+M0), preoperative completion of all three cycles of chemotherapy (SOX)
• 18-75 years old
• No incurable factors such as cancer cell metastasis in other organs
• Written informed consent signed voluntarily

Exclusion Criteria:

• Assessment of preoperative or intraoperative requiring pancreatic resection
• Gastric cancer-related emergency surgery
• Gastric stump carcinoma
• In cases of distant metastasis discovered during operation, only abdominal exploration or palliative surgery were adopt.
• Uncontrolled seizures, central nervous system diseases or mental disorders
• Uncorrectable coagulation dysfunction
• Severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases
• Diseases requiring immunosuppressive treatment, such as organ transplantation, SLE, etc
• Other diseases requiring simultaneous surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; Radical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface	Other: Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface; Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
Other: The control group; Radical gastrectomy +D2 lymphadenectomy	Other: Radical gastrectomy +D2 lymphadenectomy; Radical gastrectomy +D2 lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pancreatic fistula after radical gastrectomy	Postoperative pancreatic fistula, in which any measurable volume of fluid is delivered through a surgically placed drainage tube, has amylase activity greater than 3 times the upper limit of normal plasma value	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of pancreatic fistula	The classification of pancreatic fistula included the incidence of biochemical fistula, grade B pancreatic fistula and grade C pancreatic fistula.	3 days
the postoperative mortality	Postoperative mortality refers to the probability of death within 30 days after radical surgery for gastric cancer	30 days
length of postoperative hospital stay	Postoperative hospital stay refers to the time between the date of operation and the date of discharge	Up to 30 days
number of lymph nodes dissection	The number of lymph nodes dissected refers to the total number of lymph nodes dissected during the operation	1 days
incidence of postoperative complications	incidence of postoperative complications	30 days
incidence of TissuePatchTM related complications	intestinal adhesion, intestinal obstruction, parenchymal atrophy of the pancreas, chronic pancreatitis, and allergic reactions and so on.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical resection range	Surgical resection range	1 days
Scope of lymph node dissection	Scope of lymph node dissection	1 days
Excision range of pancreatic capsule	Excision range of pancreatic capsule	1 days
Incidence of surgical complications	Incidence of surgical complications	30 days

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Study Chair: xiaohua li, MD,PH.D, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pancreatic fistula; radical gastrectomy; TissuePatchTM
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: XJ013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No