Overview

This trial is active, not recruiting.

Condition pancreatitis
Treatments percutaneous catheter drainage, abdominal paracentesis evacuation
Sponsor University Clinical Center Tuzla
Start date January 2010
End date April 2017
Trial size 100 participants
Trial identifier NCT02648815, 04-09/2-93/15, UClinicalCenterTuzla

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Percutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis
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 drainage (APD) of peritoneal fluid during acute pancreatitis
abdominal paracentesis evacuation
Evacuation of peritoneal ascitic fluid using percutaneous catheters

Primary Outcomes

Measure
Number of participants converted to more aggressive treatment
time frame: An average of 1 year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Management of Moderate and Severe Forms of Acute Pancreatitis
Principal investigator Enver Zerem, MD.PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Clinical Center Tuzla.