Management of Pancreatitis: the Role of Supportive and Drainage Treatment

NCT ID: NCT02648815

Last Updated: 2016-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2017-07-31

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.

Conditions

Pancreatitis

Keywords

Necrotizing pancreatitis; Sepsis; Infection; Drainage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Percutaneous catheter drainage group

Percutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis

Group Type: ACTIVE_COMPARATOR

Percutaneous catheter drainage

Intervention Type: PROCEDURE

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 group

Abdominal paracentesis drainage (APD) of peritoneal fluid during acute pancreatitis

Group Type: ACTIVE_COMPARATOR

Abdominal paracentesis evacuation

Intervention Type: PROCEDURE

Evacuation of peritoneal ascitic fluid using percutaneous catheters

Interventions

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.

Intervention Type: PROCEDURE

Abdominal paracentesis evacuation

Evacuation of peritoneal ascitic fluid using percutaneous catheters

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Clinical Center Tuzla

OTHER

Sponsor Role: lead

Responsible Party

Enver Zerem

Professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enver Zerem, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinical Center Tuzla

References

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.

Reference Type: RESULT

PMID: 25320523 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21478061 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19444515 (View on PubMed)

Other Identifiers

04-09/2-93/15

Identifier Type: OTHER

Identifier Source: secondary_id

UClinicalCenterTuzla

Identifier Type: -

Identifier Source: org_study_id