Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
Primary Purpose
Pancreatic Fistula
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
Radical gastrectomy +D2 lymphadenectomy
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatic Fistula focused on measuring TissuePatchTM, radical gastrectomy, postoperative pancreatic fistula
Eligibility Criteria
Inclusion Criteria:
- Gastric adenocarcinoma confirmed by histology;
- 18-75 years old;
- No pulmonary metastasis, liver metastasis, peritoneal metastasis or other incurable factors were found in preoperative evaluation;
- Radical gastrectomy for gastric cancer;
- ECOG score 0-2;
- ASA <4;
- Good bone marrow function (leukocyte >3 x 10 ^ 9 / l; Hemoglobin> 9 g/dl. Platele>100×10^9/ L), renal function (glomerular filtration rate>60ml/min) and liver function (total bilirubin<1.5 times normal (ULN), aspartate aminotransferase (AST)< 2.5x ULN, Alanine aminotransferase (ALT<3 x ULN);
- Patients and their family members voluntarily sign written informed consent;
Exclusion Criteria:
- Preoperative evaluation requires combined pancreatectomy;
- Emergency surgery due to complications of gastric cancer;
- Only abdominal exploration or palliative surgery was performed when distant metastasis was found during the operation;
- Combined pancreatectomy was performed for intraoperative tumor invasion of pancreas;
- Gastric stump cancer;
- Patients diagnosed with primary tumors other than gastric cancer (except skin cancer and cervical cancer in situ cure);
- Pregnant or breastfeeding;
- No seizure control, central nervous system diseases or mental disorders;
- History of abdominal surgery (except laparoscopic cholecystectomy);
- The patient has coagulation dysfunction and cannot be corrected;
- Patients with heart, lung, liver, brain, kidney and other important organ failure;
- patients with metabolic diseases such as diabetes;
- Immunosuppressive therapy, such as organ transplantation, SLE, etc.;
- seriously out of control recurrent infection or other seriously out of control concomitant diseases;
- other diseases requiring simultaneous surgery;
Sites / Locations
- Xijing Hospital of Digestive DiseaseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
The experimental group
The control group
Arm Description
Radical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface
Radical gastrectomy +D2 lymphadenectomy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the postoperative mortality
Postoperative mortality refers to the probability of death within 30 days after radical surgery for gastric cancer
length of postoperative hospital stay
Postoperative hospital stay refers to the time between the date of operation and the date of discharge
Classification of pancreatic fistula
The classification of pancreatic fistula included the incidence of biochemical fistula, grade B pancreatic fistula and grade C pancreatic fistula.
number of lymph nodes dissection
The number of lymph nodes dissected refers to the total number of lymph nodes dissected during the operation
incidence of postoperative complications
incidence of postoperative complications
incidence of TissuePatchTM related complications
intestinal adhesion, intestinal obstruction, parenchymal atrophy of the pancreas, chronic pancreatitis, and allergic reactions and so on.
Full Information
NCT ID
NCT05404256
First Posted
May 30, 2022
Last Updated
April 23, 2023
Sponsor
Xijing Hospital of Digestive Diseases
1. Study Identification
Unique Protocol Identification Number
NCT05404256
Brief Title
Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula
Keywords
TissuePatchTM, radical gastrectomy, postoperative pancreatic fistula
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The experimental group
Arm Type
Experimental
Arm Description
Radical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface
Arm Title
The control group
Arm Type
Other
Arm Description
Radical gastrectomy +D2 lymphadenectomy
Intervention Type
Other
Intervention Name(s)
Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
Intervention Description
Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
Intervention Type
Other
Intervention Name(s)
Radical gastrectomy +D2 lymphadenectomy
Intervention Description
Radical gastrectomy +D2 lymphadenectomy
Primary Outcome Measure Information:
Title
Incidence of pancreatic fistula after radical gastrectomy
Description
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
Time Frame
3 days
Secondary Outcome Measure Information:
Title
the postoperative mortality
Description
Postoperative mortality refers to the probability of death within 30 days after radical surgery for gastric cancer
Time Frame
30 days
Title
length of postoperative hospital stay
Description
Postoperative hospital stay refers to the time between the date of operation and the date of discharge
Time Frame
Up to 30 days
Title
Classification of pancreatic fistula
Description
The classification of pancreatic fistula included the incidence of biochemical fistula, grade B pancreatic fistula and grade C pancreatic fistula.
Time Frame
3 days
Title
number of lymph nodes dissection
Description
The number of lymph nodes dissected refers to the total number of lymph nodes dissected during the operation
Time Frame
1 days
Title
incidence of postoperative complications
Description
incidence of postoperative complications
Time Frame
30 days
Title
incidence of TissuePatchTM related complications
Description
intestinal adhesion, intestinal obstruction, parenchymal atrophy of the pancreas, chronic pancreatitis, and allergic reactions and so on.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaohua Li, MD,PH.D
Phone
+8613474299901
Email
xjyylixiaohua@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
zhenchang Mo
Phone
+8618229712293
Email
mzc131208@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaohua li, MD,PH.D
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaohua li, MD, PH.D
Phone
13474299901
Email
lixiaohua1982@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
zhenchang mo
Phone
18229712293
Email
mzc131208@126.com
First Name & Middle Initial & Last Name & Degree
chao yue
First Name & Middle Initial & Last Name & Degree
ruiqi gao
First Name & Middle Initial & Last Name & Degree
weidong wang
12. IPD Sharing Statement
Learn more about this trial
Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
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