Post-ERCP Acute PancreatitisPhase 2NCT01855841
Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis
A Phase 2 study testing Hemin in people with Post-ERCP Acute Pancreatitis, run by Erasme University Hospital at 6 sites in 2 countries.
Trial summary
ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be effective in multiple bilio-pancreatic indications. However, one of the feared complication of this technique is acute pancreatitis, which happens in 5 to 25% of cases. 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?
- Hemin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2012to Jun 2021
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- patient for whom a pancreatic stent is inserted (Sphincter of Oddi dysfunction, ampullectomy)
- ongoing acute pancreatitis
- chronic pancreatitis (Cremer classification >=2)
- age < 18 y/o
- pregnancy
- hemin allergy
- severe renal failure (MDRD<30ml/min/1.73m2)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Belgium5 sites
CHU Brugmann
Brussels, 1020
Erasme Hospital, Université Libre de Bruxelles (ULB)
Brussels, 1070
Centre Hospitalier de Jolimont-Lobbes
Haine-St-Paul, 7100
Hôpital Ambroise Paré
Mons, 7000
ISPPC CHU Vésale
Montigny-le-Tilleul, 6110
About this study
Official title: Prevention of Post-ERCP Acute Pancreatitis by Heme-oxygenase Activation Through the Administration of Hemin : a Prospective, Randomized Double Blind Controlled Trial
ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be effective in multiple bilio-pancreatic indications. However, one of the feared complication of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient groups have been demonstrated to present a higher risk linked to individual factors or to the procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the incidence of this complication but each has his own inconvenient. Recently, the activation of heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be effective in prevention and treatment of acute pancreatitis mice models. This protective effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated by hemin. The investigators thus propose to conduct a prospective randomized double blind controlled trial to demonstrate a protective effect of hemin administration against post-ERCP acute pancreatitis in high risk patients.
Read the detailed description
Patients for who a pancreatic stent placement is indicated will be excluded from the study.
The aims of this study are: 1) to study in a pathophysiologic point of view the activation of HO-1 by hemin in human and its protective effect in post-ERCP acute pancreatitis incidence. 2) to use the human situation of post-ERCP acute pancreatitis as early pancreatitis model to study the administration of hemin as treatment of acute pancreatitis in general.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Hemin, placebo
- Keywords
- ERCP, virgin papilla, risk of post-ERCP acute pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeminDrug
Also called Haemin, Normosang
A single perfusion of 4mg/kg hemin diluted in 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein
placeboDrug
Also called saline
A single perfusion of 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein
| Study group | Role | What they receive |
|---|---|---|
| Hemin | Active comparator | A peripheral perfusion of 4mg/kg of hemin (Normosang) diluted in 100mL NaCL (sodium chloride) 0.9% will be administered in 30-60minutes as soon as possible after the end of the ERCP, followed by 100mL of NacL 0.9% to flush the vein Receives: Drug: Hemin |
| Placebo | Placebo comparator | The same amount of NaCl 0.9% (100 ML followed by a flushing perfusion of 100mL) will be perfused to the patient as soon as possible after the end of the ERCP Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-ERCP acute pancreatitis
Post-ERCP acute pancreatitis is defined by an abdominal pain compatible with pancreatitis and the elevation of seric lipases more than 3 times the upper limit of normal on days 1 post-ERCP.
Measured: at day 1 post-ERCP
Secondary outcomes (3)
severity of post-ERCP acute pancreatitis
If post-ERCP acute pancreatitis happens, all parameters of severity will be recorded (clinical, biological, intra-abdominal collections seen on abdominal scanner/magnetic resonance, organ failure, need for ICU hospitalization, need for further treatment: surgery/endoscopy/radiological drainage?)
Measured: during the hospital stay (up to 2 months)
length of stay
the length of stay in the hospital will be recorded. if a complication occurs (post-ERCP acute pancreatitis or other, it will be recorded)
Measured: during the hospitalization (up to 2 months)
safety of hemin administration
Few side effects of hemin are known (headache, superficial thrombophlebitis in the perfused vein); they will be recorded as well as other unexplained clinico-biological events
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startApr 2012
- Primary completion1 Jun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lemmers Arnaud, Erasme University Hospital
- Investigators
- Arnaud Lemmers, MD,PhD, Principal investigator, Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, BelgiumJacques Devière, MD, PhD, Study chair, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Blegium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855841
- Sponsor's protocol ID
- Hemin_AP
- Status last verified
- Jul 2021
- First submitted
- 8 May 2013
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Yared RA, Chen CC, Vandorpe A, Arvanitakis M, Delhaye M, Viesca MFY, Huberty V, Blero D, Toussaint E, Hittelet A, Verset D, Margos W, Le Moine O, Njimi H, Liao WC, Deviere J, Lemmers A. Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial. Pancreatology. 2024 May;24(3):363-369. doi: 10.1016/j.pan.2024.02.009. Epub 2024 Feb 15.
PubMed 38431445
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-ERCP Acute Pancreatitis by Heme-oxygenase Activation Through the Administration of Hemin : a Prospective, Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01855841
- Acronym / sponsor ID
- Hemin_AP
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- ERCP, virgin papilla, risk of post-ERCP acute pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 17 May 2013 (estimated)
- 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.
ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be effective in multiple bilio-pancreatic indications. However, one of the feared complication of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient groups have been demonstrated to present a higher risk linked to individual factors or to the procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the incidence of this complication but each has his own inconvenient. Recently, the activation of heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be effective in prevention and treatment of acute pancreatitis mice models. This protective effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated by hemin. The investigators thus propose to conduct a prospective randomized double blind controlled trial to demonstrate a protective effect of hemin administration against post-ERCP acute pancreatitis in high risk patients.
Detailed description
Patients for who a pancreatic stent placement is indicated will be excluded from the study.
The aims of this study are: 1) to study in a pathophysiologic point of view the activation of HO-1 by hemin in human and its protective effect in post-ERCP acute pancreatitis incidence. 2) to use the human situation of post-ERCP acute pancreatitis as early pancreatitis model to study the administration of hemin as treatment of acute pancreatitis in general.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemin | Active comparator | Drug: HeminA peripheral perfusion of 4mg/kg of hemin (Normosang) diluted in 100mL NaCL (sodium chloride) 0.9% will be administered in 30-60minutes as soon as possible after the end of the ERCP, followed by 100mL of NacL 0.9% to flush the vein |
| Placebo | Placebo comparator | Drug: placeboThe same amount of NaCl 0.9% (100 ML followed by a flushing perfusion of 100mL) will be perfused to the patient as soon as possible after the end of the ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- patient for whom a pancreatic stent is inserted (Sphincter of Oddi dysfunction, ampullectomy)
- ongoing acute pancreatitis
- chronic pancreatitis (Cremer classification >=2)
- age < 18 y/o
- pregnancy
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 |
|---|---|---|
| HeminAlso: Haemin, NormosangA single perfusion of 4mg/kg hemin diluted in 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein | Drug | Hemin |
| placeboAlso: salineA single perfusion of 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein | Drug | Placebo |
Primary outcome
Incidence of post-ERCP acute pancreatitis
Time frame: at day 1 post-ERCP
Post-ERCP acute pancreatitis is defined by an abdominal pain compatible with pancreatitis and the elevation of seric lipases more than 3 times the upper limit of normal on days 1 post-ERCP.
3 secondary outcomes
severity of post-ERCP acute pancreatitis
Time frame: during the hospital stay (up to 2 months)
length of stay
Time frame: during the hospitalization (up to 2 months)
safety of hemin administration
Time frame: within 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 7 Jul 2021.
- Derived from this study: PubMed 38431445Yared RA, Chen CC, Vandorpe A, Arvanitakis M, Delhaye M, Viesca MFY, Huberty V, Blero D, Toussaint E, Hittelet A, Verset D, Margos W, Le Moine O, Njimi H, Liao WC, Deviere J, Lemmers A. Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial. Pancreatology. 2024 May;24(3):363-369. doi: 10.1016/j.pan.2024.02.009. Epub 2024 Feb 15.
Related trials for Post-ERCP Acute Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Not yet recruiting
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
Recruiting
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
RecruitingObservational study
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Post-ERCP Acute Pancreatitis
Not yet recruitingPhase 4
Indomethacin for Biliary ERCP Patients
Pancreatitis Biliary, Pancreatitis Acute Biliary
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.
Arnaud Lemmers, MD,PhD principal investigator
Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium
Jacques Devière, MD, PhD study chair
Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Blegium
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemin in people with Post-ERCP Acute Pancreatitis, run by Erasme University Hospital at 6 sites in 2 countries.
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 0 inclusion and 7 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of post-ERCP acute pancreatitis (time frame: at day 1 post-ERCP). 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 NCT01855841, 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 7 Jul 2021.