Clinical trial NCT03643900: The Efficacy of Pancreatic Duct Stenting With Rectal Indomethacin in Preventing Post-ERCP Pancreatitis
Official title: Clinical Research on the Prophylactic Efficacy of Pancreatic Duct Stenting Combined With Rectal Indomethacin Drug on Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-ERCP Pancreatitis
Pancreatitis, Acute Necrotizing
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Age over 18 years old,gender is not limited; Preoperative blood amylase is normal; PEP risk factors during surgery:difficulty in intubation,needle knife incision,intraoperative intubation into the pancreatic duct more than 3 times,the contrast agent in the pancreatic duct is filled; The research procedure is willing to be followed and the informed consent is signed.

Exclusion Criteria:

Myocardial infarction occurred within 3 months; Insufficiency of renal function; Conventional gastrectomy; Preoperative state of shock,such as hypotension(systolic blood pressure less than 90mmHg); Pregnancy and lactation; Allergic to NSAIDs drugs; Partially or completely restricted in the ability to exercise consciousness,without self-determination ability; Are participating in other clinical observation trials or have participated in other clinical trials within 60 days; Cases considered unsuitable by the investigator.

Primary outcomes:
measure: the incidence of PEP
timeFrame: 24 hours
Secondary outcomes:
measure: CT severity index
timeFrame: 72 hours
measure: the incidence of severe PEP
timeFrame: 7 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Jianfeng Yang
role: PRINCIPAL_INVESTIGATOR
References: