UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033798
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute PGIMER, Chandigarh
Institute
Department

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
URL(English) https://upload.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


Contact us.