Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis

3. maj 2014 opdateret af: Zhujiang Hospital

The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis in Chinese Population.

The purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases SAP patients from April 2014 to April 2015 who carry on the treatment in our hospital,and divide into the experimental group and control group under respect the wishes of patient in the case.The experimental group use the method of laparoscopic-assisted percutaneous drainage to carry on the treatment,the control group patients use conventional conservative therapy to carry on the treatment.Contrastive analyze two groups of patients clinical care effects.

Research hypothesis:according to compare the mortality,the incidence of complications ,hospital stay and other research indicators of two groups .It is supposed that the research indicators of experimental group are lower than the control group ,difference was statistically significant(P<0.05).We can draw the conclusion that the method of laparoscopic-assisted percutaneous catheter drainage of early SAP is useful and deserve to be promoted on clinical.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

According to the unified inclusion and exclusion criteria,We are going to select 60 cases SAP patients who carry on the treatment in our hospital from April 2014 to April 2015,and divide into the experimental group and control group under respect the wishes of patients.

The experimental group use the method of laparoscopic-assisted percutaneous catheter-directed drainage of SAP.According to different causes,.For patients with simple gallbladder stones,it is going to carry out by laparoscopic cholecystectomy or cholecystotomy.For patients with both gallbladder and common bile duct stones,common bile duct exploration is performed.Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline.The postoperation therapeutic program is same as the control group.

The control group use the method of conventional conservative therapy without surgical management,the principles of treatment include:(1)fasting,insert gastric tube,gastrointestinal decompression;(2)complement of blood volume,keeping water ,electrolyte and acid base balance;(3)inhibiting pancreatic enzyme and acid secretion;(4)using broad-spectrum antibiotic at the early phase;(5)improving microcirculation,dextrans and FuFangdanshen by IV;(6)early parenteral nutrition;(7)treatment by chinese herbs;(8)strengthen the function of important organs.

Contrastive analyse two groups of patient's mortality,the incidence of complications,hospital stay,laboratory tests and other research indicators.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510280
        • Rekruttering
        • Department of Hepatobiliary Surgery(I),Zhujiang Hospital
        • Ledende efterforsker:
          • Fan y fang, Prof.

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

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:Possessing the clinical performance and biochemical changes of acute pancreatitis,as well as one of the following items:

  • organ dysfunction(one organ or multiple organs)
  • local complications(pancreatic necrosis;pancreatic abscess;pancreatic pseudocyst);Ronson score of ≥3;
  • APACHE-Ⅱscore of ≥8;
  • Balthazar CT grade D or grade E.

Exclusion Criteria:

  • mild acute pancreatitis;
  • chronic acute pancreatitis;
  • on admission has received surgical treatment;
  • pregnant and lactating women ;combined with heart,lung,liver,kidney severe primary disease;psychopath;
  • malignant tumor
  • immunocompromised state.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: surgical operation therapy
Using the method of laparoscopic-assisted percutaneous catheter drainage of SAP.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline.
Procedure: laparoscopic-assisted percutaneous catheter drainage
Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline
Andre navne:
  • surgical therapy
Medicin: 0.5% 5-fluorouracil normal saline
On the one hand,0.5% 5-fluorouracil normal saline directly inhibit DNA synthesis of pancreatic acinar cells which result in the synthesis of amylopsin of and trypsase is restrained.On the other hand,it can induce pancreatic cells apoptosis and alleviate pancreatic necrosis.
Andre navne:
  • 5-FU
  • f5U
Ingen indgriben: conventional therapy
using the method of conventional conservative therapy without surgical management.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
dødelighed
Tidsramme: et år
et år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the incidence of local Complications
Tidsramme: within the first 30 days (plus or minus 3 days) after surgery
the local complications include:pancreatic necrosis,pancreatic abscess,pancreatic pseudocyst etc.
within the first 30 days (plus or minus 3 days) after surgery

Andre resultatmål

Resultatmål
Tidsramme
hospital stay
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zhujiang Hospital

Efterforskere

  • Ledende efterforsker: Fan y fang, Prof., Department of Hepatobiliary Surgery(I),Zhujiang Hospital

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

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. april 2014

Primær færdiggørelse (Forventet)

1. april 2015

Studieafslutning (Forventet)

1. april 2015

Datoer for studieregistrering

Først indsendt

28. april 2014

Først indsendt, der opfyldte QC-kriterier

3. maj 2014

Først opslået (Skøn)

7. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Fanyingfang1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pancreatitis, Akut Nekrotiserende

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner