Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

NCT ID: NCT01687959

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-08-31

Brief Summary

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Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography for acute biliary pancreatitis is a controversial issue. There are still many confounding findings offering either early laparoscopic cholecystectomy within 72 hours following endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is known to be an important factor in peritoneal healing and adhesion formation. Measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.

Detailed Description

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Peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion formation. It is expected that endoscopic retrograde cholangiography is a trauma causing adhesions around the hepatobiliary area. Such adhesions may cause some difficulty for consequent gallbladder surgery. For that reason, tissue measurements of factors indicating degree of peritoneal healing and adhesion is helpful for timing of such surgical interventions.

Patients are going to be randomized to early and delayed surgery groups. Sampling of peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after endoscopic retrograde cholangiography is performed. Tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are going to be studied by using commercial assays.

Peritoneal fibrinolytic activity and surgical outcomes are going to be compared.

Conditions

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Cholelithiasis Associated With Common Bile Duct Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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activity of peritoneal fibrinolysis

measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1

Group Type ACTIVE_COMPARATOR

tissue sampling from peritoneum of the gallbladder

Intervention Type OTHER

tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis

surgical outcomes

surgical outcomes of laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

tissue sampling from peritoneum of the gallbladder

Intervention Type OTHER

tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis

Interventions

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tissue sampling from peritoneum of the gallbladder

tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis

Exclusion Criteria

* contraindication to laparoscopy
* unsuccessful endoscopic retrograde cholangiography
* complicated acute biliary pancreatitis
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Hasbahceci

MD, general surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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department of general surgery; Bezmialem vakif university

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BEZM-LC-postERCP

Identifier Type: -

Identifier Source: org_study_id

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