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The Cost Effectiveness of Endoscopic Ultrasound ( EUS ) Based Strategy in Diagnosis of Common Bile Duct Stones

23. ledna 2015 aktualizováno: Nisa Netinatsunton, Prince of Songkla University

The Cost Effectiveness Between EUS-based Strategy Versus Endoscopic Retrograde Cholangiopancreatography ( ERCP )-Based Strategy in Diagnosis of Common Bile Duct Stones in Patients With Intermediate Risk: a Study in Developing Country.

Multiple reports in the literature showed the efficacy of EUS comparable to ERCP in the diagnosis of common bile duct ( CBD ) stone. The EUS-based strategy has provided the cost effectiveness in diagnosis of CBD stone in defined patient risk groups was showed in previous studies. The aim of our study was to assess the cost effectiveness of EUS based strategy versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risks for CBD stones in a real working situation in a developing country.

Přehled studie

Detailní popis

Background: Multiple reports showed the efficacy of EUS comparable to ERCP in the diagnosis of CBD stone. The EUS-based strategy has provided the cost saving in diagnosis of CBD stone in patients with intermediate risk in previous studies in western population. There were multiple parameters involved the cost effectiveness analysis included cost of ERCP, cost of EUS, prevalence of CBD stones, the sensitivity and specificity of EUS and the rate of complications related to EUS and ERCP. These parameter may vary from center to center and from region to region.

Aims: To assess the cost effectiveness of EUS based strategy versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risk in a developing country.

Method : A prospective study in 141 patients with suspected CBD stones based on clinical, biochemical and imaging by trans-abdominal ultrasonography or computed abdominal tomography. All patients underwent EUS. All patients with high risk for CBD stone underwent ERCP after the EUS. For patients with intermediate risk for CBD stone, ERCP's were done at the discretion of the attending physicians. For patients with ERCP done, the diagnosis of CBD stone was confirmed by ERCP demonstration of CBD stone. In patients with intermediate risk without ERCP done, clinical follow up to assess biliary symptoms and liver function test as surrogated markers for CBD stone at 3 months interval for one year were done. The false negative rate in patients with EUS and ERCP done in this study was used to estimate the false negative rate in patients in clinical surrogated group.

Definition: High risk of CBD stones was defined when CBD stone was detected by US/CT or dilated duct with abnormal liver function test ( LFT ). Intermediate risk of CBD stones was defined when US/CT showed normal bile duct with abnormal LFT or dilated duct with normal LFT.

Cost analysis :The cost of making diagnosis of CBD stone excluding all costs of treatment was analyzed. The cost of all patients with suspected CBD stones undergoing ERCP was calculated and compared with the strategy of EUS follow by ERCP. The cost was evaluated by (1) mean costs of EUS and ERCP based on the actual cost in our center which included costs of medical staffs, disposable materials, drugs, equipment amortization and maintenance. (2) cost associated with complications induced by the procedure.

Statistical analysis: Test performance of the endoscopic ultrasound in diagnosis of CBD stones was analyzed with two by two tables. The sensitivity, specificity, positive and negative predictive values were calculated.

Typ studie

Pozorovací

Zápis (Aktuální)

141

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Songkhla
      • Hatyai, Songkhla, Thajsko, 90110
        • NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

All patients with suspected CBD stones based on clinical, biochemical and imaging by trans-abdominal ultrasonography or computed tomography..

Popis

Inclusion Criteria:

  • history of biliary pain or recent cholangitis
  • acute pancreatitis
  • abnormal liver function test
  • dilatation of CBD and or CBD stone detected by trans-abdominal ultrasound and or computed tomography.

Exclusion Criteria:

  • unstable hemodynamics
  • severe coagulopathy
  • refusal to participate

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
High risk group
High risk group was defined when CBD stones was detected by ultrasound ( US ) / computed tomography ( CT ) or dilated duct with abnormal LFT.
Patients with high risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. All patients even if negative EUS examination of CBD stone were underwent ERCP in the same session. The ERCPs were performed in standard manner. All patients were contacted by phone on day 1, 3 and 30 after the procedure.
Ostatní jména:
  • EUS examination follow by ERCP
Intermediate risk group
Intermediate risk group was defined when US/CT showed normal bile duct with abnormal LFT or dilated duct with normal LFT.
Patients with intermediate risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. ERCPs were done at the discretion of the attending physicians. The ERCPs were performed in standard manner. The patients without ERCP done were contacted at 3 months interval to assess symptoms and LFT for 12 months.
Ostatní jména:
  • EUS examination follow by ERCP or clinical follow up

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The cost of making diagnosis of CBD stone
Časové okno: within 12 months after EUS
The cost of making diagnosis of CBD stone will be measured as the difference in the cost of all patients undergoing ERCP and ERCP follow by EUS intervention. The cost was evaluated by (1) mean costs of EUS and ERCP based on the actual cost in our center which included costs of medical staffs, disposable materials, drugs, equipment amortization and maintenance. (2) costs associated with complications induced by the procedure.
within 12 months after EUS

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The accuracy of EUS in diagnosis of CBD stone
Časové okno: within 12 months after EUS
This will be measured as proportion of patients who encounter a correctly diagnosis of CBD stone by EUS. Positive EUS finding was confirmed by ERCP. Negative EUS finding was confirmed by ERCP or absence of symptoms for 12 months.
within 12 months after EUS
The safety of EUS and ERCP procedure
Časové okno: within 1 months
This will be measured as proportion of patients who encounter a procedural complication (%) during EUS and ERCP that includes pancreatitis, perforation or hemorrhage
within 1 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Bancha Ovartlarnporn, MD, NKC Institue of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkla, Thailand.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2012

Primární dokončení (Aktuální)

1. prosince 2013

Dokončení studie (Aktuální)

1. prosince 2014

Termíny zápisu do studia

První předloženo

16. ledna 2015

První předloženo, které splnilo kritéria kontroly kvality

23. ledna 2015

První zveřejněno (Odhad)

29. ledna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

29. ledna 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. ledna 2015

Naposledy ověřeno

1. ledna 2015

Více informací

Termíny související s touto studií

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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3
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