Management of Pancreatitis: the Role of Supportive and Drainage Treatment

October 27, 2016 updated by: Enver Zerem, University Clinical Center Tuzla

Management of Moderate and Severe Forms of Acute Pancreatitis

This study aims to investigate the natural clinical course, diagnostic possibilities and treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The management of severe acute pancreatitis varies with the severity and depends on the type of complication that requires treatment. Although no universally accepted treatment algorithm exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage, followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to produce superior outcomes to traditional open necrosectomy and may be considered as the reference standard intervention for this disorder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Despite overall reduced mortality in the last decade, MSAP and SAP are devastating diseases associated with mortality ranging from less than 10% to as high as 85%, according to various studies. The management of SAP is complicated because of the limited understanding of the pathogenesis and multi-causality of the disease, uncertainties in outcome prediction and few effective treatment modalities. Generally, sterile necrosis can be managed conservatively in the majority of cases with a low mortality rate (12%). However, infection of pancreatic necrosis can be observed in 25%-70% of patients with necrotizing disease; it is generally accepted that the infected non-vital tissue should be removed to control the sepsis. Laparotomy and immediate debridement of the infected necrotic tissue have been the gold standard treatment for decades. However, several reports have shown that early surgical intervention for pancreatic necrosis could result in a worse prognosis compared to cases where surgery is delayed or avoided. Therefore, several groups worldwide have developed new, minimally invasive approaches for managing infected necrotizing pancreatitis. The applicability of these techniques depends on the availability of specialized expertise and a multidisciplinary team dedicated to the management of SAP and its complications.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. fluid collections within two weeks of disease onset;
  2. single- or multi-organ failure;
  3. CTSI > = 7 (initial CT performed within 7 days after the onset of disease.); and (4) acute physiology and chronic health evaluation (APACHE) II score > = 8.

Exclusion Criteria:

  1. patients without APD interventions;
  2. patients who underwent necrosectomy directly after APD without PCD as a bridge therapy;
  3. previous percutaneous drainage or surgical necrosectomy during the episode of pancreatitis;
  4. previous exploratory laparotomy for acute abdomen and intraoperative diagnosis of AP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Percutaneous catheter drainage group
Percutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis
Procedure: Percutaneous catheter drainage
Depending on the operator experience, tandem trocar technique or Seldinger technique can be used. If the Seldinger technique is used, then the catheter tract should be sequentially dilated over a guidewire. Access routes that avoid crossing the bowel and other intervening organs, or major mesenteric, peripancreatic, or retroperitoneal blood vessels are selected to minimize the risk of bacterial contamination and hemorrhage. Successful percutaneous treatment of necrotic collections of the pancreas depends on several important factors. Catheters often need to remain in place for several weeks and sometimes months; hence, close follow-up is required.
ACTIVE_COMPARATOR: Abdominal paracentesis evacuation group
Abdominal paracentesis drainage (APD) of peritoneal fluid during acute pancreatitis
Procedure: Abdominal paracentesis evacuation
Evacuation of peritoneal ascitic fluid using percutaneous catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants converted to more aggressive treatment
Time Frame: An average of 1 year
An average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients requiring PCD after initial APD
Time Frame: An average of 1 year
An average of 1 year
Morbidity and mortality in patients requiring PCD
Time Frame: An average of 1 year
An average of 1 year
Number of PCD interventions required
Time Frame: An average of 1 year
An average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinical Center Tuzla

Investigators

  • Principal Investigator: Enver Zerem, MD.PhD, University Clinical Center Tuzla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

December 31, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (ESTIMATE)

January 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UClinicalCenterTuzla
  • 04-09/2-93/15 (OTHER: University Clinical Center Tuzla)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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