Clinical trial NCT02648815: Management of Pancreatitis: the Role of Supportive and Drainage Treatment
Official title: Management of Moderate and Severe Forms of Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis
Keywords: Necrotizing pancreatitis
Sepsis
Infection
Drainage
Lead sponsor: University Clinical Center Tuzla
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants converted to more aggressive treatment
timeFrame: An average of 1 year
Secondary outcomes:
measure: Proportion of patients requiring PCD after initial APD
timeFrame: An average of 1 year
measure: Morbidity and mortality in patients requiring PCD
timeFrame: An average of 1 year
measure: Number of PCD interventions required
timeFrame: An average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University Clinical Center Tuzla
name: Enver Zerem, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zerem E. Treatment of severe acute pancreatitis and its complications. World J Gastroenterol. 2014 Oct 14;20(38):13879-92. doi: 10.3748/wjg.v20.i38.13879.
citation: Zerem E, Imamovic G, Susic A, Haracic B. Step-up approach to infected necrotising pancreatitis: a 20-year experience of percutaneous drainage in a single centre. Dig Liver Dis. 2011 Jun;43(6):478-83. doi: 10.1016/j.dld.2011.02.020. Epub 2011 Apr 8.
citation: Zerem E, Imamovic G, Omerovic S, Imsirovic B. Randomized controlled trial on sterile fluid collections management in acute pancreatitis: should they be removed? Surg Endosc. 2009 Dec;23(12):2770-7. doi: 10.1007/s00464-009-0487-2. Epub 2009 May 15.