Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05404256 |
| Other study ID # |
XJ013 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
April 1, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Xijing Hospital of Digestive Diseases |
| Contact |
xiaohua Li, MD,PH.D |
| Phone |
+8613474299901 |
| Email |
xjyylixiaohua[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
