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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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 | From the endoscopic treatment of post-sphincterotomy-bleeding up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the endoscopic treatment of post-sphincterotomy-bleeding up to three days |
| Increasing of cholestasis parameters |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Schmitz, Dr.med. | Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic | Mannheim | 68165 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17509029 | Background | 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. | |
| 8782497 | Background | Freeman 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| From treatment of post-sphincterotomy-bleeding up to three days |
| 2070995 | Background | 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. |
| 10650275 | Background | Matsushita 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. |