Management of Pancreatitis: the Role of Supportive and Drainage Treatment

Pancreatitis Clinical Trial

Official title:

Management of Moderate and Severe Forms of Acute Pancreatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02648815
• Other study ID #: UClinicalCenterTuzla
• Secondary ID: 04-09/2-93/15
• Status: Active, not recruiting
• Phase: N/A
• First received: December 31, 2015
• Last updated: October 27, 2016
• Start date: January 2010
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: University Clinical Center Tuzla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis

Intervention

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.
• Abdominal paracentesis evacuation
Evacuation of peritoneal ascitic fluid using percutaneous catheters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Clinical Center Tuzla

References & Publications (3)

Zerem E, Imamovic G, Omerovic S, Imširovic 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. — View Citation

Zerem E, Imamovic G, Sušic 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants converted to more aggressive treatment		An average of 1 year	Yes
Secondary	Proportion of patients requiring PCD after initial APD		An average of 1 year	Yes
Secondary	Morbidity and mortality in patients requiring PCD		An average of 1 year	Yes
Secondary	Number of PCD interventions required		An average of 1 year	Yes