Post-ERCP PancreatitisNCT03643900
The Efficacy of Pancreatic Duct Stenting With Rectal Indomethacin in Preventing Post-ERCP Pancreatitis
A study testing pancreatic duct stenting and rectal indomethacin in people with Post-ERCP Pancreatitis and Pancreatitis, Acute Necrotizing, run by First People's Hospital of Hangzhou at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Pancreatitis, Pancreatitis, Acute Necrotizing
- What is being tested?
- pancreatic duct stenting and rectal indomethacin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2018to 18 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research on the Prophylactic Efficacy of Pancreatic Duct Stenting Combined With Rectal Indomethacin Drug on Post Endoscopic Retrograde Cholangiopancreatography 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.
- 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.
- Research methods: Patients were randomly divided into indometacin suppositories, indomethacin suppositories and pancreatic stents.
- 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.
Read the 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.
- 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.
- Being tested
- pancreatic duct stenting, rectal indomethacin
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic duct stentingDevice
Also called pancreatic stent
Place the pancreatic duct stent
rectal indomethacinDrug
Also called Indomethacin Suppositories
rectal indomethacin 100mg at preoperative 30min
| Study group | Role | What they receive |
|---|---|---|
| indomethacin with stenting group | Experimental | Pancreatic duct stenting and rectal indomethacin 100mg at preoperative 30min in 100 patients Receives: Device: pancreatic duct stenting; Drug: rectal indomethacin |
| indomethacin group | Active comparator | Rectal indomethacin 100mg at preoperative 30min in 100 patients Receives: Drug: rectal indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of PEP
the rate of patients with PEP
Measured: 24 hours
Secondary outcomes (2)
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
Measured: 72 hours
the incidence of severe PEP
the rate of patients with severe acute pancreatitis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start8 Aug 2018
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Jianfeng Yang, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643900
- Sponsor's protocol ID
- 2018053013
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2018
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Prophylactic Efficacy of Pancreatic Duct Stenting Combined With Rectal Indomethacin Drug on Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
- ClinicalTrials.gov ID
- NCT03643900
- Acronym / sponsor ID
- 2018053013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Research methods: Patients were randomly divided into indometacin suppositories, indomethacin suppositories and pancreatic stents.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indomethacin with stenting group | Experimental | Device: pancreatic duct stenting, Drug: rectal indomethacinPancreatic duct stenting and rectal indomethacin 100mg at preoperative 30min in 100 patients |
| indomethacin group | Active comparator | Drug: rectal indomethacinRectal indomethacin 100mg at preoperative 30min in 100 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreatic duct stentingAlso: pancreatic stentPlace the pancreatic duct stent | Device | indomethacin with stenting group |
| rectal indomethacinAlso: Indomethacin Suppositoriesrectal indomethacin 100mg at preoperative 30min | Drug | indomethacin group, indomethacin with stenting group |
Primary outcome
the incidence of PEP
Time frame: 24 hours
the rate of patients with PEP
2 secondary outcomes
CT severity index
Time frame: 72 hours
the incidence of severe PEP
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Post-ERCP Pancreatitis
RecruitingPhase 3
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
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Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
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Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfeng Yang principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreatic duct stenting and rectal indomethacin in people with Post-ERCP Pancreatitis and Pancreatitis, Acute Necrotizing, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of PEP (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.