Fluid Collections Management in Severe Acute Pancreatitis

NCT ID: NCT01321060

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.

Detailed Description

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Conditions

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Acute Pancreatitis Acute Pancreatic Fluid Collection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative treatment

Conservative treatment group with only drugs.

Group Type ACTIVE_COMPARATOR

Conservative treatment

Intervention Type DRUG

Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation

Continuous catheter drainage

Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.

Group Type EXPERIMENTAL

Catheter drainage

Intervention Type PROCEDURE

Repeated aspiration

Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.

Group Type EXPERIMENTAL

Aspiration

Intervention Type PROCEDURE

Interventions

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Aspiration

Intervention Type PROCEDURE

Catheter drainage

Intervention Type PROCEDURE

Conservative treatment

Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
* CT density \< 30Hu
* Within 7 days from the onset of the disease
* Available approach for percutaneous penetrate

Exclusion Criteria

* Pregnant pancreatitis
* Receiving surgery or aspiration before;need of early surgery
* Infected fluid collection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role collaborator

Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Weiqin Li

Director of surgical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of SICU, Research Institute of General Surgery Jinling Hospital,

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiqin Li, Dr

Role: CONTACT

+86-025-80860066

Zhihui Tong, Dr

Role: CONTACT

+86-025-80860066

Facility Contacts

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Weiqin Li, Dr

Role: primary

+86-025-80860066

Other Identifiers

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RIGS

Identifier Type: -

Identifier Source: org_study_id

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