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Post-ERCP Acute PancreatitisNCT01431781

The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

A study testing Stilamin+common daily treatment and Common daily practice in people with Post-ERCP Acute Pancreatitis, run by Changhai Hospital at 15 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde Cholangiopancreatography), the incidence rate is 5\&-10%, how to prevent PEP and hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-ERCP Acute Pancreatitis
What is being tested?
Stilamin+common daily treatment and Common daily practice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
908 participants
Where
15 sitesChina
Study dates
Aug 2011to Mar 2013
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

  • Males and females, age > 18 years.
  • Normal amylase level before undergoing ERCP.
  • Signed inform consent form and agreed to follow-up on time.

Who cannot join

  • Pregnancy or history of allergy to somatostatin.
  • Renal insufficiency (Scr>177umol/L).
  • Acute myocardial infarction within 3 months of the procedure.
  • History of subtotal gastrectomy (Billroth II Method).
  • Symptom of shock before undergoing ERCP, such as hypotension (systolic blood pressure < 90mmHg) or tachycardia (HR > 120 bpm).
  • Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent .
Show all 9Show fewer
  • Patients involved in other study within 60 days.
  • Patients unfitted for the study by investigators.
  • All contraindications to Stilamin.

Trial locations and contacts

15 sites in 1 country.

Shen Zh Li, Pro. contact

(021)25070684

15 sites in 1 country

China15 sites, 1 recruiting

  • Beijing Friendship Hospital

    Beijing

    Active, not recruiting

  • Xinan Hospital

    Chongqing

    Active, not recruiting

  • Fujian Province Hospital

    Fuzhou, Fujian

    Active, not recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong

    Active, not recruiting

  • The People' Hospital of Heilongjiang Province

    Haerbin, Heilongjiang

    Active, not recruiting

  • Hangzhou First People Hospital

    Hangzhou, Zhejiang

    Active, not recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Active, not recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Active, not recruiting

  • Jiangsu Province of TCM

    Nanjing

    Active, not recruiting

  • Changhai Hospital

    Shanghai

    Shen Zh Li, Pro.

    Recruiting

  • Eastern Hepatobiliary Surgery Hospital

    Shanghai

    Active, not recruiting

  • Shanghai First People Hospital

    Shanghai

    Active, not recruiting

  • Wulumuqi General Hospital of Chinese PLA

    Ürümqi, Xinjiang

    Active, not recruiting

  • Tongji Hospital

    Wuhan

    Active, not recruiting

  • Xijing Hospital

    Xi’an, Shanxi

    Active, not recruiting

Other trials in China

About this study

Official title: A Prospective, Multi-center, Investigator Sponsored, Randomized Controlled Trial-- The Prophylactic Effect of Stilamin on Post-ERCP Pancreatitis

Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde Cholangiopancreatography), the incidence rate is 5\&-10%, how to prevent PEP and hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas treatment. In order to explore the effects of somatostatin on prevent PEP(post-ERCP Pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given common treatment, the other uses somatostatin in the base of common treatment.

Read the detailed description

A prospective, multi-center, investigator sponsored, randomized controlled trial, 15 sites join in in China, 908 subjects will be enrolled.

A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.

Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Being tested
Stilamin+common daily treatment, Common daily practice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stilamin+common daily treatmentDrug

    Also called Somatostatin:Stilamin

    dose:250 micrograms bolus intravenous in 3 minutes when ERCP starts and continuous infusion for 11 hours after ERCP.

    Common daily treatment: fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory.

  • Common daily practiceOther

    Also called Common daily practice including:, Fasted for 6h after ERCP,, Fluid replacement,, Gastric acid inhibition,

    Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory

Study groups in NCT01431781
Study groupRoleWhat they receive
stilamin+common daily treatmentExperimentalNot described
Receives: Drug: Stilamin+common daily treatment
common daily treatmentActive comparatorNot described
Receives: Other: Common daily practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the prophylaxis effect of Stilamin on post-ERCP pancreatitis

    If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours, patients also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).

    A descriptive analysis will be performed on primary endpoint, containing frequecency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.

    Measured: the incidence rate of PEP at 24 h after ERCP in two groups

Secondary outcomes (2)

  1. the prophylaxis effect of Stilamin in sub-groups of patient with high risk

    If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).

    Descriptive statistics will be produced for all continuous variables.Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

    Measured: PEP occurence rate at 24 h after ERCP at high-risk patients in two groups

  2. compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events.

    Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms.During the study, any unexpected medical issue will be called adverse event.

    Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

    Measured: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2012 (estimated)
  4. Study completionMar 2013 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
908 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01431781
Sponsor's protocol ID
02324789755
Status last verified
Sep 2011
First submitted
7 Sep 2011
Last updated
27 Sep 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Bai Y, Ren X, Zhang XF, Lv NH, Guo XG, Wan XJ, Nie ZG, Han ST, Bie P, Tian DA, Ji M, Li ZS. Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial. Endoscopy. 2015 May;47(5):415-20. doi: 10.1055/s-0034-1391227. Epub 2015 Jan 15.

    PubMed 25590178

Questions about this trial

What is this clinical trial studying?

A study testing Stilamin+common daily treatment and Common daily practice in people with Post-ERCP Acute Pancreatitis, run by Changhai Hospital at 15 sites 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shen Zh Li, Pro. ((021)25070684), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the prophylaxis effect of Stilamin on post-ERCP pancreatitis (time frame: the incidence rate of PEP at 24 h after ERCP in two groups). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01431781, which also lists 1 linked publication.

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 27 Sep 2011.

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