NCT01687959

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

September 14, 2012

Last Update Submit

January 27, 2015

Conditions

Cholelithiasis Associated With Common Bile Duct Stones

Keywords

cholelithiasislaparoscopic cholecystectomyendoscopic sphincterotomycholedocholithiasis

Outcome Measures

Primary Outcomes (1)

  • 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

    six months

Secondary Outcomes (1)

  • surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography

    six months

Study Arms (2)

activity of peritoneal fibrinolysis

ACTIVE COMPARATOR

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

Other: tissue sampling from peritoneum of the gallbladder

surgical outcomes

ACTIVE COMPARATOR

surgical outcomes of laparoscopic cholecystectomy

Other: tissue sampling from peritoneum of the gallbladder

Interventions

tissue sampling from peritoneum of the gallbladderOTHER

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

activity of peritoneal fibrinolysissurgical outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis

You may not qualify if:

  • contraindication to laparoscopy
  • unsuccessful endoscopic retrograde cholangiography
  • complicated acute biliary pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of general surgery; Bezmialem vakif university

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CholelithiasisCholedocholithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesCommon Bile Duct DiseasesBile Duct Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, general surgeon

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 19, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

TU(1)