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

Primary Purpose

Cholelithiasis Associated With Common Bile Duct Stones

Status

Unknown status

Phase

Early Phase 1

Locations

Turkey

Study Type

Interventional

Intervention

tissue sampling from peritoneum of the gallbladder

About this trial

This is an interventional treatment trial for Cholelithiasis Associated With Common Bile Duct Stones focused on measuring cholelithiasis, laparoscopic cholecystectomy, endoscopic sphincterotomy, choledocholithiasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis

Exclusion Criteria:

contraindication to laparoscopy
unsuccessful endoscopic retrograde cholangiography
complicated acute biliary pancreatitis

Sites / Locations

department of general surgery; Bezmialem vakif university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

activity of peritoneal fibrinolysis

surgical outcomes

Arm Description

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

surgical outcomes of laparoscopic cholecystectomy

Outcomes

Primary Outcome Measures

measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography

measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1

Secondary Outcome Measures

surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography

evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy

Full Information

NCT ID

NCT01687959

First Posted

September 14, 2012

Last Updated

January 27, 2015

Sponsor

Bezmialem Vakif University

1. Study Identification

Unique Protocol Identification Number

NCT01687959

Brief Title

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

Official Title

Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bezmialem Vakif University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholelithiasis Associated With Common Bile Duct Stones

Keywords

cholelithiasis, laparoscopic cholecystectomy, endoscopic sphincterotomy, choledocholithiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

activity of peritoneal fibrinolysis

Arm Type

Active Comparator

Arm Description

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

Arm Title

surgical outcomes

Arm Type

Active Comparator

Arm Description

surgical outcomes of laparoscopic cholecystectomy

Intervention Type

Other

Intervention Name(s)

tissue sampling from peritoneum of the gallbladder

Intervention Description

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

Primary Outcome Measure Information:

Title

measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography

Description

measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1

Time Frame

six months

Secondary Outcome Measure Information:

Title

surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography

Description

evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy

Time Frame

six months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis Exclusion Criteria: contraindication to laparoscopy unsuccessful endoscopic retrograde cholangiography complicated acute biliary pancreatitis

Facility Information:

Facility Name

department of general surgery; Bezmialem vakif university

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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