Comparison of Effectiveness of TissePatchTM in Preventing Postoperative Pancreatic Fistula

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    60
  • sponsor
    Xijing Hospital of Digestive Diseases
Updated on 7 October 2022

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.

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.

Details
Condition Pancreatic Fistula
Treatment Radical gastrectomy of gastric cancer +TissePatchTM to cover pancreatic capsule wound, Radical gastrectomy for gastric cancer
Clinical Study IdentifierNCT05404256
SponsorXijing Hospital of Digestive Diseases
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Gastric adenocarcinoma confirmed by histology
-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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note