UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033798
Receipt number R000038559
Scientific Title LAVAGE VERSUS NO LAVAGE THROUGH PERCUTANEOUS CATHETER DRAINS IN SEVERE ACUTE PANCREATITIS: A RANDOMIZED CONTROL TRIAL
Date of disclosure of the study information 2018/08/18
Last modified on 2018/08/18 14:59:11

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Basic information

Public title

LAVAGE VERSUS NO LAVAGE THROUGH PERCUTANEOUS CATHETER DRAINS IN SEVERE ACUTE PANCREATITIS: A RANDOMIZED CONTROL TRIAL

Acronym

LAVAGE VERSUS NO LAVAGE THROUGH PERCUTANEOUS CATHETER DRAINS IN SEVERE ACUTE PANCREATITIS

Scientific Title

LAVAGE VERSUS NO LAVAGE THROUGH PERCUTANEOUS CATHETER DRAINS IN SEVERE ACUTE PANCREATITIS: A RANDOMIZED CONTROL TRIAL

Scientific Title:Acronym

LAVAGE VERSUS NO LAVAGE THROUGH PERCUTANEOUS CATHETER DRAINS IN SEVERE ACUTE PANCREATITIS

Region

Asia(except Japan)


Condition

Condition

Pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Reversal of preexisting organ failure
Need for surgical intervention
Development of infective and non infective complications
New onset organ failure
Impact on mortality

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reversal of preexisting organ failure
Need for surgical intervention
Development of infective and non infective complications
New onset organ failure
Impact on mortality

Key secondary outcomes

Assess the length of ICU Stay and Hospital Stay


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lavage through percutaneous drains

Interventions/Control_2

no lavage in control group

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

12 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

All patients diagnosed as MSAP/SAP with PCD placement and admitted in the Department of Surgery and Department of Gastroenterology, PGIMER between July 2013 to December 2014 were recruited

Key exclusion criteria

Hemorrhage in the lesser sac which precluded percutaneous drainage
Previous surgical necrosectomy for infected pancreatic necrosis prior to referral
Refusal by the patient

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Pavneet Kohli

Organization

Post Graduate Institute of Medical Reserach, Chandigarh

Division name

Department of General Surgery

Zip code


Address

PGIMER, Chandigarh, India

TEL

919888536824

Email

kohli.pavneet@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Vikas Gupta

Organization

PGIMER, Chnadigarh

Division name

Department of General Surgery

Zip code


Address

PGIMER, Chandigarh, India

TEL

919872041120

Homepage URL


Email

vikaspgi@gmail.com


Sponsor or person

Institute

PGIMER, Chandigarh

Institute

Department

Personal name



Funding Source

Organization

PGIMER, CHandigarh

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 18 Day

Last modified on

2018 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038559


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name