Comparison of Effectiveness of TissePatchTM in Preventing Postoperative Pancreatic Fistula

Sponsor
Xijing Hospital of Digestive Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05404256
Collaborator
(none)
60
1
2
5
11.9

Study Details

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 TissePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissePatchTM 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Radical gastrectomy of gastric cancer +TissePatchTM to cover pancreatic capsule wound
  • Other: Radical gastrectomy for gastric cancer
N/A

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. 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. TissePatchTM 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 TissePatchTM 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 TissePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissePatchTM 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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Randomized Controlled Trial for Comparison of the Effects of Preventing Postoperative Pancreatic Fistula by With Versus Without TissePatchTM Cover the Wound Surface of Pancreatic Capsule
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: The experimental group

Radical gastrectomy of gastric cancer +TissePatchTM to cover pancreatic capsule wound

Other: Radical gastrectomy of gastric cancer +TissePatchTM to cover pancreatic capsule wound
Radical gastrectomy of gastric cancer +TissePatchTM to cover pancreatic capsule wound

Other: The control group

Radical gastrectomy for gastric cancer

Other: Radical gastrectomy for gastric cancer
Radical gastrectomy for gastric cancer

Outcome Measures

Primary Outcome Measures

  1. Incidence of pancreatic fistula after radical gastrectomy for gastric cancer [3 days]

    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

  1. Classification of pancreatic fistula [3 days]

    The classification of pancreatic fistula included the incidence of biochemical fistula, grade B pancreatic fistula and grade C pancreatic fistula.

Other Outcome Measures

  1. Surgical resection range [1 days]

    Surgical resection range

  2. Scope of lymph node dissection [1 days]

    Scope of lymph node dissection

  3. Excision range of pancreatic capsule [1 days]

    Excision range of pancreatic capsule

  4. Incidence of surgical complications [30 days]

    Incidence of surgical complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xijing Hospital of Digestive Disease Xi'an Shaanxi China 710032

Sponsors and Collaborators

  • Xijing Hospital of Digestive Diseases

Investigators

  • Study Chair: xiaohua li, MD,PH.D, Xijing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
xiaohua li, Associate chief physician, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier:
NCT05404256
Other Study ID Numbers:
  • XJ013
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by xiaohua li, Associate chief physician, Xijing Hospital of Digestive Diseases
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022