Laparoscopic Cholecystectomy in Idiopathic Pancreatitis | NCT00784355

Studies
Laparoscopic Cholecystectomy in Idiopathic Pancreatitis

NCT00784355

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Aug 14, 2018Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Idiopathic Pancreatitis

Interventions

Laparoscopic cholecystectomy

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Oct 31, 2008

First Submission Date that Met QC Criteria

Oct 31, 2008

First Posted Date

Nov 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2018

Last Update Posted Date

Aug 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are caused by microlithiasis in gall bladder. The purpose of this randomized study is to prevent recurrence of idiopathic pancreatitis by performing laparoscopic cholecystectomy compared to non-operative group in 2 years follow-up of patients.

Detailed Description

Etiologic investigations include serum amylase, lipase, triglyceride and calcium determination, as well as abdominal ultrasound scanning. Alcohol consumption is asked by using WHO audit test. After etiology of acute pancreatitis has been confirmed as idiopathic, 100 patients are randomized to laparoscopic cholecystectomy and 100 patients to follow-up of 2 years. Five to seven Finnish university and main central hospitals are participating the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1:Laparoscopic cholecystectomy	Experimental	Surgery	Procedure: Laparoscopic cholecystectomy
2:controls	No Intervention	non-surgical control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic cholecystectomy	Procedure	Surgery	1:Laparoscopic cholecystectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence of acute pancreatitis		2 years

Secondary Outcomes

Measure	Description	Time Frame
etiology of acute pancreatitis in Finland in 2009-10		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

idiopathic pancreatitis

Exclusion Criteria:

age < 18 years old
patients' refusal
high operative risks
alcohol overuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hannu EK Paajanen, MD, PhD	Contact	+358-44-3512220		hannu.paajanen@kuh.fi
Sari Paajanen, MD, PhD	Contact			hannu.paajanen@kuh.fi

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital	Recruiting	Kuopio		70211	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10470320	Background	Karne S, Gorelick FS. Etiopathogenesis of acute pancreatitis. Surg Clin North Am. 1999 Aug;79(4):699-710. doi: 10.1016/s0039-6109(05)70036-0.
26583660	Derived	Raty S, Pulkkinen J, Nordback I, Sand J, Victorzon M, Gronroos J, Helminen H, Kuusanmaki P, Nordstrom P, Paajanen H. Can Laparoscopic Cholecystectomy Prevent Recurrent Idiopathic Acute Pancreatitis?: A Prospective Randomized Multicenter Trial. Ann Surg. 2015 Nov;262(5):736-41. doi: 10.1097/SLA.0000000000001469.

ID	Term
D017081	Cholecystectomy, Laparoscopic
D002763	Cholecystectomy

ID	Term
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D010535	Laparoscopy