The Study of Laparoscopic-assisted Percutaneous Catheter-directed Drainage to Treat Early Severe Acute Pancreatitis
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Wang li qing, doctor
- Telefonnummer: +86-02062783391
- E-Mail: wliqing07@gmail.com
Studienorte
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Guangdong
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Guangzhou, Guangdong, China, 510280
- Rekrutierung
- Department of Hepatobiliary Surgery(I),Zhujiang Hospital
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Hauptermittler:
- Fan y fang, Prof.
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
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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
Andere Namen:
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.
Andere Namen:
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Kein Eingriff: conventional therapy
using the method of conventional conservative therapy without surgical management.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Sterblichkeit
Zeitfenster: ein Jahr
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ein Jahr
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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the incidence of local Complications
Zeitfenster: within the first 30 days (plus or minus 3 days) after surgery
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the local complications include:pancreatic necrosis,pancreatic abscess,pancreatic pseudocyst etc.
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within the first 30 days (plus or minus 3 days) after surgery
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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hospital stay
Zeitfenster: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Fan y fang, Prof., Department of Hepatobiliary Surgery(I),Zhujiang Hospital
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Erkrankungen der Bauchspeicheldrüse
- Pankreatitis
- Pankreatitis, akut nekrotisierend
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Fluorouracil
Andere Studien-ID-Nummern
- Fanyingfang1
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