Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06076252 |
Other study ID # |
PJKT2023-061 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2023 |
Est. completion date |
August 31, 2028 |
Study information
Verified date |
April 2023 |
Source |
Affiliated Hospital of Guangdong Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The incidence rate and mortality rate of periampullary cancer at home and abroad both show an
increasing trend, seriously affecting the health level of the people. Pancrecoduodenectomy
(PD) is the only effective treatment for periampullary cancer. However, due to the complex
technology and difficulty of PD surgery, laparoscopic pancreaticoduodenectomy (LPD) is more
difficult, and the postoperative mortality can reach 5%. The important reason is the most
serious complication- -pancreatic fistula. The occurrence of pancreatic fistula is related to
many factors, and the most critical factor is the method and technology of
pancreatico-intestinal anastomosis, so the improvement and innovation of
pancreaticoco-intestinal anastomosis technology has always been a hot topic in surgical
clinical research. Blumgart Pancreatic anastomosis was originally created by Professor
L.H.Blumgart in the United States, and was widely used in OPD due to its low incidence of
pancreatic fistula. However, the traditional Blumgart anastomosis is complicated and is not
suitable for application in LPD. According to our own experience, our team simplified and
improved the traditional Blumgart anastomosis to OPD, and through retrospective study, it has
the advantages of reducing the incidence of pancreatic fistula. However, the application
value in LPD still needs to be further discussed. Therefore, this study intends to use a
prospective randomized controlled trial, using the LPD patients with traditional Blumgart
pancreatecointestinal anastomosis as the control group, and the LPD patients with modified
Blumgart pancreatecointestinal anastomosis as the test group, compare the clinical relevant
indicators and the incidence of postoperative complications, and explore whether the
application value in LPD can truly simplify the surgical procedure and ensure the lower
incidence of pancreatic leakage.
Description:
This study intends to use a prospective randomized controlled trial, the LPD patients with
traditional Blumgart anastomosis as the control group, design the LPD patients with modified
Blumgart anastomosis as the test group, by comparing the clinical correlation index and the
rate of postoperative complications in LPD can truly simplify the surgical procedure and
ensure the lower rate of pancreatic leakage.
The following steps will be followed:
1. Patients who met the inclusion criteria and did not meet the exclusion criteria
underwent modified Blumgart anastomosis according to the randomization LPD surgery group
(test group) or LPD surgery group with conventional Blumgart pancreatecreenterostomy
(control group).
2. The following common LPD procedure was used in the test and control groups: ①
Preoperative preparation and anesthesia mode Preoperative gastric tube, urinary tube and
central venous channel; general anesthesia ② Same surgical procedure: Establishment of
artificial pneumoperitoneum and operating hole anatomical exploratory specimen resection
and reconstruction of digestive tract (biliary intestine kiss Combination,
gastrointestinal anastomosis) drain placement.
3. In the test group, the pancreatic intestine anastomosis in the LPD Combined, the control
group used conventional Blumgart pancreatestatic anastomosis.
4. Both postoperative groups were routinely given anti-infection, gastric mucosa
protection, somatostatin, and nutritional supportive therapy. After the first Remove
gastric tube and urinary catheter on 3 days, instructed patients to eat cold liquid food
and ambulation; somatostatin was stopped on postoperative day 5, The upper abdominal CTA
was reviewed, and the remaining treatment plans were formulated according to the actual
situation of the patient. Postoperative numbers 1,3,5, and For 7 days, the relevant
drainage indexes, daily drainage rate, drainage properties and amylase content were
reviewed.
5. If the patient can be discharged with the following conditions: the general condition is
good, and the normal diet and intestinal function are basically restored; Body
temperature was normal and the abdominal examination showed no positive signs; relevant
laboratory results were almost normal; CTA Significant abdominal effusion and other
abnormalities; postoperative abdominal incision healed well.
6. After discharge, pay attention to their appetite, spirit, urine and feces, and drainage
tube (discharged with drainage tube). Patients without special discomfort were returned
to the hospital for review once at 1and 3 months after surgery.