Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03643900 |
Other study ID # |
2018053013 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 8, 2018 |
Est. completion date |
August 18, 2021 |
Study information
Verified date |
August 2021 |
Source |
First People's Hospital of Hangzhou |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
With the development of endoscopic technology, ERCP has been widely used in the diagnosis and
treatment of pancreatobiliary diseases, and has become the first treatment for most of the
biliary and pancreatic diseases. Postoperative ERCP pancreatitis (PEP) is the most common and
serious complication after ERCP. The purpose of this study was to explore methods for
preventing postoperative pancreatitis.
1. Participants: Patients with high-risk factors associated with PEP were included in the
no-obvious patients who underwent therapeutic ERCP in our hospital from June 2018 to
December 2019.
2. Research methods: Patients were randomly divided into indometacin suppositories,
indomethacin suppositories and pancreatic stents.
3. Statistical methods: SPSS 13.0 statistical software was used. The measurement data was
expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used
for count data.
Description:
Patients with high risk factors for PEP who will be examined and diagnosed by ERCP at
2018.06-2019.12 in the First People's Hospital of Hangzhou are randomly divided into two
groups.
2. Record the relevant indicators of each group of patients: 1 before and after surgery 3,
12, 24 h serum amylase changes 2 patients with abdominal pain, abdominal distension, fever,
vomiting and abdominal signs of change; 3 hospital days; 4 CT severity index (CT severity
Index, CTSI score: Balthazar 5 scores were scored as 0 to 4 points; according to the scope of
necrosis was divided into no, <33%, 33% to 50%,> 50%, respectively rated as 0, 2, 4 and 6
points. Addition of the two scores is the CTSI score. 5 According to the diagnostic criteria
for postoperative ERCP pancreatitis, PEP will be diagnosed in patients with persistent
abdominal pain within 24 hours after ERCP and blood amylase increase by more than 3 times the
normal value. Observed 2 groups of post-ERCP pancreatitis, severe pancreatitis and adverse
events Incidence.
3. Analyze and compare the above indicators and observe the effect of the two methods on the
reduction of blood amylase level and incidence of pancreatitis. It is clear that rectal
administration of preoperative indomethacin suppository has the same protection against PEP
as pancreatic stenting effect.