Endoscopic Biliary SphincterotomyNCT03725319
Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Plastic Stent
An observational study of Endoscopic Biliary Sphincterotomy and Bleeding, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
Trial summary
Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Biliary Sphincterotomy, Bleeding
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 29 Oct 2018to 15 Dec 2018
- 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 documented ERCPs in the single centre institution database are systematically screened for post sphincterotomy-bleeding in the time period from 1.1.2002 to 29.10.2018
Who may be able to join
- Post sphincterotomy bleeding (PSB) of the papilla (time frame: from procedure up to ten days after the procedure)
- Treatment of PSB by epinephrine-injection or insertion of a plastic stent into the common bile duct
Who cannot join
- Pregnant and/or lactating women
- Complete patient record is not available
Trial locations and contacts
1 site in 1 country.
Germany1 site
Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic
Mannheim, 68165
About this study
Official title: Retrospective Study on Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Endoprosthesis: a Single Center Experience Over 16 Years With 5698 ERCPs
Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases.
There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident.
Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice.
A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.
Read the detailed description
Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases.
The increasing use of antiplatelet and/or anticoagulant therapies enhances the risk of PSB.
There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident.
Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice.
A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.
In detail, clinical success and safety of the procedure, re-bleeding rate, number of re-interventions and days of hospital stay will be analysed.
- Conditions
- Endoscopic Biliary Sphincterotomy, Bleeding
- Keywords
- Endoscopic Biliary Sphincterotomy, Endoscopic Retrograde Cholangiopancreatography, Bleeding, Epinephrine, Stent
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epinephrin injection | Diluted Epinephrin (1:100) in small amounts from 1 to 5 ml is injected into apex of the papilla to stop post sphincterotomy-bleeding | |
| Plastic stent insertion | A plastic stent (diameter: 8-11,5F and length of 50 -100mm) is inserted into the common bile duct to stop post sphincterotomy-bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
No re-bleeding occurs in the follow-up that requirers a further interventional treatment of re-bleeding (any endoscopic, radiological embolization or surgery): yes/no
Measured: From the successful endocopic treatment of post sphincterotomy-bleeding up to 30 days in the follow up
Re-interventions
Amount of endoscopic re-interventions (further endoscopic therapy of re-bleeding of the papilla, removal or exchange of the plastic stent): number (n)
Measured: From the endoscopic treatment of post-sphincterotomy-bleeding up to three months
Hospital stay after treatment
Hospital stay (days) after treatment of post sphincterotomy-bleeding
Measured: From the endoscopic treatment of post-sphincterotomy-bleeding up to 30 days
Secondary outcomes (2)
Post ERCP-pancreatitis
Any kind of post ERCP-pancreatitis that occurs after treatment of post sphincterotomy-bleeding and can be refered to this treatment (patients with cannulated pancreatic duct are excluded): yes/no
Measured: From the endoscopic treatment of post-sphincterotomy-bleeding up to three days
Increasing of cholestasis parameters
Any kind of cholestasis measured by an increase of bilirubin level (mg/dl) after the treatment of post-sphincterotomy-bleeding that can be refered to this treatment (patients with unsuccesful endoscopic drainage/stone extraction are excluded): yes/no
Measured: From treatment of post-sphincterotomy-bleeding up to three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start29 Oct 2018
- Primary completion30 Nov 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Biliary SphincterotomyStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Investigators
- Daniel Schmitz, Dr.med., Principal investigator, Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725319
- Sponsor's protocol ID
- PSB Epiverstent 01
- Status last verified
- Mar 2020
- First submitted
- 29 Oct 2018
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
PubMed 17509029Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
PubMed 8782497Cotton 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 2070995Matsushita M, Hajiro K, Takakuwa H, Nishio A. Effective hemostatic injection above the bleeding site for uncontrolled bleeding after endoscopic sphincterotomy. Gastrointest Endosc. 2000 Feb;51(2):221-3. doi: 10.1016/s0016-5107(00)70425-1. No abstract available.
PubMed 10650275
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Endoprosthesis: a Single Center Experience Over 16 Years With 5698 ERCPs
- ClinicalTrials.gov ID
- NCT03725319
- Acronym / sponsor ID
- PSB Epiverstent 01
- Conditions
- Endoscopic Biliary Sphincterotomy, Bleeding
- Keywords
- Endoscopic Biliary Sphincterotomy, Endoscopic Retrograde Cholangiopancreatography, Bleeding, Epinephrine, Stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 31 Oct 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.
Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases.
There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident.
Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice.
A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.
Detailed description
Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases.
The increasing use of antiplatelet and/or anticoagulant therapies enhances the risk of PSB.
There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident.
Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice.
A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.
In detail, clinical success and safety of the procedure, re-bleeding rate, number of re-interventions and days of hospital stay will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrin injection | – | –Diluted Epinephrin (1:100) in small amounts from 1 to 5 ml is injected into apex of the papilla to stop post sphincterotomy-bleeding |
| Plastic stent insertion | – | –A plastic stent (diameter: 8-11,5F and length of 50 -100mm) is inserted into the common bile duct to stop post sphincterotomy-bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All documented ERCPs in the single centre institution database are systematically screened for post sphincterotomy-bleeding in the time period from 1.1.2002 to 29.10.2018
Key inclusion criteria (2 listed)
- Post sphincterotomy bleeding (PSB) of the papilla (time frame: from procedure up to ten days after the procedure)
- Treatment of PSB by epinephrine-injection or insertion of a plastic stent into the common bile duct
Key exclusion criteria (2 listed)
- Pregnant and/or lactating women
- Complete patient record is not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical success
Time frame: From the successful endocopic treatment of post sphincterotomy-bleeding up to 30 days in the follow up
No re-bleeding occurs in the follow-up that requirers a further interventional treatment of re-bleeding (any endoscopic, radiological embolization or surgery): yes/no
Re-interventions
Time frame: From the endoscopic treatment of post-sphincterotomy-bleeding up to three months
Amount of endoscopic re-interventions (further endoscopic therapy of re-bleeding of the papilla, removal or exchange of the plastic stent): number (n)
Hospital stay after treatment
Time frame: From the endoscopic treatment of post-sphincterotomy-bleeding up to 30 days
Hospital stay (days) after treatment of post sphincterotomy-bleeding
2 secondary outcomes
Post ERCP-pancreatitis
Time frame: From the endoscopic treatment of post-sphincterotomy-bleeding up to three days
Increasing of cholestasis parameters
Time frame: From treatment of post-sphincterotomy-bleeding up to three 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 19 Mar 2020.
- Background: PubMed 17509029Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
- Background: PubMed 8782497Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
- 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 10650275Matsushita M, Hajiro K, Takakuwa H, Nishio A. Effective hemostatic injection above the bleeding site for uncontrolled bleeding after endoscopic sphincterotomy. Gastrointest Endosc. 2000 Feb;51(2):221-3. doi: 10.1016/s0016-5107(00)70425-1. No abstract available.
- Individual participant dataSharing planned: No
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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.
Daniel Schmitz, Dr.med. principal investigator
Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim
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 Endoscopic Biliary Sphincterotomy and Bleeding, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
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 2 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 19 Mar 2020. 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 Germany. 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?
Clinical success (time frame: From the successful endocopic treatment of post sphincterotomy-bleeding up to 30 days in the follow up). The study lists 3 primary outcomes in all. 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 NCT03725319, which also lists 4 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 19 Mar 2020.