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NCT Number: NCT03643900

The Efficacy of Pancreatic Duct Stenting With Rectal Indomethacin in Preventing Post-ERCP Pancreatitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

About this study

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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pancreatic duct stenting

Device

Place the pancreatic duct stent

Other names: pancreatic stent

Rectal Indomethacin

Drug

rectal indomethacin 100mg at preoperative 30min

Other names: Indomethacin Suppositories

Primary outcomes

  1. the incidence of PEP

    Time frame: 24 hours

    the rate of patients with PEP

Secondary outcomes

  1. CT severity index

    Time frame: 72 hours

    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

  2. the incidence of severe PEP

    Time frame: 7 days

    the rate of patients with severe acute pancreatitis

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

Clinical Research on the Prophylactic Efficacy of Pancreatic Duct Stenting Combined With Rectal Indomethacin Drug on Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2018
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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