Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones
1. december 2015 opdateret af: Yanglin Pan, Air Force Military Medical University, China
Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination
ERCP is the primary choice for removal of common bile duct stone (CBDS) currently.
However, 4-24% patients underwent recurrence after successful clearance of CBDS.
Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy.
Although it was believed that DBR was the important cause of CBDS recurrence, the direct evidence was still lacking.
Here we conducted a case control study to investigate the DBR rate in patients with recurrent CBDS after ERCP.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
64
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710032
- Xijing Hospital of Digestive Diseases
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with history of recurrent common bile duct stone (recurrent group) and non-recurrent common bile duct stone (control group) in Xijing Hospital of Digestive Diseases were invited to participate the study.
All the patients underwent successful stone removal by ERCP previously.
Patients in the control group were matched with the recurrence group by age and gender at 1:1 ratio.
Beskrivelse
Inclusion Criteria:
- Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.
Exclusion Criteria:
- Gallbladder stones or hepatolithiasis;
- Stenosis of biliary duct;
- Incomplete common bile duct stone removal by ERCP;
- Common bile duct stent;
- Unable to provide informed consent.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Recurrent group
Patients with history of recurrent common bile duct stone after successfully ERCP stone remove.
|
All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.
|
|
Control group
Patients without history of recurrent common bile duct stone after successfully ERCP stone remove.
|
All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duodenal-biliary reflux rate
Tidsramme: up to 6 months
|
The proportion of patients with barium reflux into bile duct during the standard barium meal examination.
|
up to 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Distal common bile duct angle
Tidsramme: up to 6 months
|
MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.
|
up to 6 months
|
|
Maximal CBD diameter
Tidsramme: up to 6 months
|
Maximal CBD diameter was determined by MRCP.
|
up to 6 months
|
|
Peripapillary diverticulum
Tidsramme: up to 6 months
|
Peripapillary diverticulum was defined endoscopically as the presence of a diverticulum within a 2-cm radius from the papilla and was divided into 2 types in terms of the relation between the papilla and diverticulum: type A, papilla located on the inner rim of the diverticulum or papilla located deep within the diverticulum; and type B, papilla located outside the diverticulum.
|
up to 6 months
|
|
Pneumobilia
Tidsramme: up to 6 months
|
Pneumobilia were determined by CT
|
up to 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Cheon YK, Lehman GA. Identification of risk factors for stone recurrence after endoscopic treatment of bile duct stones. Eur J Gastroenterol Hepatol. 2006 May;18(5):461-4. doi: 10.1097/00042737-200605000-00001.
- Ando T, Tsuyuguchi T, Okugawa T, Saito M, Ishihara T, Yamaguchi T, Saisho H. Risk factors for recurrent bile duct stones after endoscopic papillotomy. Gut. 2003 Jan;52(1):116-21. doi: 10.1136/gut.52.1.116.
- Keizman D, Ish Shalom M, Konikoff FM. Recurrent symptomatic common bile duct stones after endoscopic stone extraction in elderly patients. Gastrointest Endosc. 2006 Jul;64(1):60-5. doi: 10.1016/j.gie.2006.01.022.
- Ishiguro J. Biliary bacteria as an indicator of the risk of recurrence of choledocholithiasis after endoscopic sphincterotomy. Diagn Ther Endosc. 1998;5(1):9-17. doi: 10.1155/DTE.5.9.
- Kim DI, Kim MH, Lee SK, Seo DW, Choi WB, Lee SS, Park HJ, Joo YH, Yoo KS, Kim HJ, Min YI. Risk factors for recurrence of primary bile duct stones after endoscopic biliary sphincterotomy. Gastrointest Endosc. 2001 Jul;54(1):42-8. doi: 10.1067/mge.2001.115335. Erratum In: Gastrointest Endosc 2002 Jan;55(1):144. Chol WB [corrected to Choi WB].
- Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc. 2009 Aug;70(2):317-21. doi: 10.1016/j.gie.2008.12.054. Epub 2009 Jun 21.
- Zhang R, Luo H, Pan Y, Zhao L, Dong J, Liu Z, Wang X, Tao Q, Lu G, Guo X. Rate of duodenal-biliary reflux increases in patients with recurrent common bile duct stones: evidence from barium meal examination. Gastrointest Endosc. 2015 Oct;82(4):660-5. doi: 10.1016/j.gie.2015.03.1908. Epub 2015 May 5.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2013
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
20. december 2014
Først indsendt, der opfyldte QC-kriterier
31. december 2014
Først opslået (Skøn)
1. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20130508-2
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