Biliary ObstructionERCPURANCT05886127
Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.
An observational study of Biliary Obstruction and Complication of Treatment, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
The aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ERCP (endoscopic retrograde cholangiopancreatography ) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction, Complication of Treatment
- What is being tested?
- A novel hemostatic agent (Purastat®)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2022to 30 Oct 2023
- Phase
- Observational
- 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
Study population: All consecutive patients indicated for ERCP with sphincterotomy or precut at our endoscopy centre. Patients are mostly reffered from adjacent territory belonging to our hospital (non-selected cohort)
Who may be able to join
- . All patients indicated for ERCP with papilosphincterotomy or precut.
- Participant is willing and able to give informed consent for participation in the study
Who cannot join
- Known allergy to a novel hemostatic agent
- Gravidity
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Petr Hrabak
Prague, 16000
petr hrabak, 224962580, petr.hrabak@vfn.cz
About this study
Official title: Treatment of Immediate and Prevention of Delayed Bleeding After Endoscopic Retrograde Cholangiopancreatography Sphincterothomy or Precut With a Novel Self-assembling Peptide Hemostatic Gel. A Single Centre Prospective Observational Nonrandomized Study
The aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ERCP (endoscopic retrograde cholangiopancreatography )
Read the detailed description
ERCP with sfincterotomy or precut is connected with procedural or/and postprocedural bleeding. Estimated risk of bleeding is from 2% to 10%. Procedural bleeding is usually managed by diluted epinephrine injection, balloon tamponade, hemoclip or fully covered metalic self-expanding stent placement. There is no standard preventive treatment for patients with higher risk of delayed post-sphincterotomy bleeding. PuraStat®, 3D Matrix Europe SAS, Caluire-et-Cuire, France) is synthetic self-assembling peptide haemostatic gel indicated to stop bleeding from small blood vessel or oozing from capillaries. Purastat® is easily aplicated through a catheter during the ERCP procedure and it is not significantly prolonging the procedure. The transparent gel is not compromising the endoscopic view and enables to continue in procedure if necessary.
All patients after ERCP sfincterotomy or precut will recieve Purastat® during the procedure Adverse events (bleeding, cholangoitis, pancreatitis) will be monitored during following 4 weeks (ambulatory after hospital discharge) This cohort will be compared to historical control, when Purastat® was not available tu use.
- Conditions
- Biliary Obstruction, Complication of Treatment
- Being tested
- A novel hemostatic agent (Purastat®)
- Keywords
- ERCP, A novel haemostatic agent, Postsfincterothomy bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel hemostatic agent (Purastat®)Device
A novel hemostatic agent (Purasta®) will be applied on cutted ampulla of Vater
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ERCP with papilosphincterotomy or precut | All patients after ERCP papilosphincterotomy or precut will receive a novel hemostatic agent (Purastat®) Receives: Device: A novel hemostatic agent (Purastat®) | |
| Historical control | All patients who had ERCP with papilosphincterotomy or precut in the previous period, when a novel hemostatic gel (Purastat®) was not available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding episodes after ERCP sfincterothomy or precut
Measured: One month
Secondary outcomes (1)
Number of nonbleeding complications after ERCP sfincterothomy or precut
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Biliary ObstructionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Hrabak, General University Hospital, Prague
- Investigators
- Petr Hrabak, Principal investigator, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886127
- Sponsor's protocol ID
- ERCP-PURA/1
- Acronym
- ERCPURA
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be presented at Czech and Slovak gastroenterology meeting conference 2023 and in a peer-review journal.
Publications
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
PubMed 2070995Subramaniam S, Kandiah K, Chedgy F, Fogg C, Thayalasekaran S, Alkandari A, Baker-Moffatt M, Dash J, Lyons-Amos M, Longcroft-Wheaton G, Brown J, Bhandari P. A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2021 Jan;53(1):27-35. doi: 10.1055/a-1198-0558. Epub 2020 Jul 17.
PubMed 32679602de Nucci G, Reati R, Arena I, Bezzio C, Devani M, Corte CD, Morganti D, Mandelli ED, Omazzi B, Redaelli D, Saibeni S, Dinelli M, Manes G. Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding. Endoscopy. 2020 Sep;52(9):773-779. doi: 10.1055/a-1145-3412. Epub 2020 Apr 21.
PubMed 32316041Lin WC, Lin HH, Hung CY, Shih SC, Chu CH. Clinical endoscopic management and outcome of post-endoscopic sphincterotomy bleeding. PLoS One. 2017 May 17;12(5):e0177449. doi: 10.1371/journal.pone.0177449. eCollection 2017.
PubMed 28545082Tsou YK, Lin CH, Liu NJ, Tang JH, Sung KF, Cheng CL, Lee CS. Treating delayed endoscopic sphincterotomy-induced bleeding: epinephrine injection with or without thermotherapy. World J Gastroenterol. 2009 Oct 14;15(38):4823-8. doi: 10.3748/wjg.15.4823.
PubMed 19824118
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Immediate and Prevention of Delayed Bleeding After Endoscopic Retrograde Cholangiopancreatography Sphincterothomy or Precut With a Novel Self-assembling Peptide Hemostatic Gel. A Single Centre Prospective Observational Nonrandomized Study
- ClinicalTrials.gov ID
- NCT05886127
- Acronym / sponsor ID
- ERCPURA / ERCP-PURA/1
- Conditions
- Biliary Obstruction, Complication of Treatment
- Keywords
- ERCP, A novel haemostatic agent, Postsfincterothomy bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 2 Jun 2023 (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.
The aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ERCP (endoscopic retrograde cholangiopancreatography )
Detailed description
ERCP with sfincterotomy or precut is connected with procedural or/and postprocedural bleeding. Estimated risk of bleeding is from 2% to 10%. Procedural bleeding is usually managed by diluted epinephrine injection, balloon tamponade, hemoclip or fully covered metalic self-expanding stent placement. There is no standard preventive treatment for patients with higher risk of delayed post-sphincterotomy bleeding. PuraStat®, 3D Matrix Europe SAS, Caluire-et-Cuire, France) is synthetic self-assembling peptide haemostatic gel indicated to stop bleeding from small blood vessel or oozing from capillaries. Purastat® is easily aplicated through a catheter during the ERCP procedure and it is not significantly prolonging the procedure. The transparent gel is not compromising the endoscopic view and enables to continue in procedure if necessary.
All patients after ERCP sfincterotomy or precut will recieve Purastat® during the procedure Adverse events (bleeding, cholangoitis, pancreatitis) will be monitored during following 4 weeks (ambulatory after hospital discharge) This cohort will be compared to historical control, when Purastat® was not available tu use.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ERCP with papilosphincterotomy or precut | – | Device: A novel hemostatic agent (Purastat®)All patients after ERCP papilosphincterotomy or precut will receive a novel hemostatic agent (Purastat®) |
| Historical control | – | –All patients who had ERCP with papilosphincterotomy or precut in the previous period, when a novel hemostatic gel (Purastat®) was not available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients indicated for ERCP with sphincterotomy or precut at our endoscopy centre. Patients are mostly reffered from adjacent territory belonging to our hospital (non-selected cohort)
Key inclusion criteria (2 listed)
- . All patients indicated for ERCP with papilosphincterotomy or precut.
- Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (3 listed)
- Known allergy to a novel hemostatic agent
- Gravidity
- Inability to sign informed consent
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 |
|---|---|---|
| A novel hemostatic agent (Purastat®)A novel hemostatic agent (Purasta®) will be applied on cutted ampulla of Vater | Device | Patients undergoing ERCP with papilosphincterotomy or precut |
Primary outcome
Number of bleeding episodes after ERCP sfincterothomy or precut
Time frame: One month
1 secondary outcome
Number of nonbleeding complications after ERCP sfincterothomy or precut
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Background: PubMed 2070995Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
- Background: PubMed 32679602Subramaniam S, Kandiah K, Chedgy F, Fogg C, Thayalasekaran S, Alkandari A, Baker-Moffatt M, Dash J, Lyons-Amos M, Longcroft-Wheaton G, Brown J, Bhandari P. A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2021 Jan;53(1):27-35. doi: 10.1055/a-1198-0558. Epub 2020 Jul 17.
- Background: PubMed 32316041de Nucci G, Reati R, Arena I, Bezzio C, Devani M, Corte CD, Morganti D, Mandelli ED, Omazzi B, Redaelli D, Saibeni S, Dinelli M, Manes G. Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding. Endoscopy. 2020 Sep;52(9):773-779. doi: 10.1055/a-1145-3412. Epub 2020 Apr 21.
- Background: PubMed 28545082Lin WC, Lin HH, Hung CY, Shih SC, Chu CH. Clinical endoscopic management and outcome of post-endoscopic sphincterotomy bleeding. PLoS One. 2017 May 17;12(5):e0177449. doi: 10.1371/journal.pone.0177449. eCollection 2017.
- Background: PubMed 19824118Tsou YK, Lin CH, Liu NJ, Tang JH, Sung KF, Cheng CL, Lee CS. Treating delayed endoscopic sphincterotomy-induced bleeding: epinephrine injection with or without thermotherapy. World J Gastroenterol. 2009 Oct 14;15(38):4823-8. doi: 10.3748/wjg.15.4823.
- Individual participant dataSharing planned: Yes. The results will be presented at Czech and Slovak gastroenterology meeting conference 2023 and in a peer-review journal.
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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.
Petr Hrabak principal investigator
General University Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Obstruction and Complication of Treatment, run by General University Hospital, Prague at 1 site in Czechia.
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 2 inclusion and 3 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 2 Jun 2023. 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 Czechia. 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 Petr Hrabak, MD (224962580 ext. +420, petr.hrabak@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bleeding episodes after ERCP sfincterothomy or precut (time frame: One month). 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 NCT05886127, which also lists 5 linked publications.
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 2 Jun 2023.