Management of Pancreatitis: the Role of Supportive and Drainage Treatment

NCT02648815 | Unknown DMC

• 2 other identifiers: UClinicalCenterTuzla04-09/2-93/15
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatitis

Keywords

Necrotizing pancreatitis; Sepsis; Infection; Drainage

Outcome Measures

Primary Outcomes (1)

• Number of participants converted to more aggressive treatment

  An average of 1 year

Secondary Outcomes (3)

• Proportion of patients requiring PCD after initial APD

  An average of 1 year

• Morbidity and mortality in patients requiring PCD

  An average of 1 year

• Number of PCD interventions required

  An average of 1 year

Study Arms (2)

Percutaneous catheter drainage group

ACTIVE COMPARATOR

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

Procedure: Percutaneous catheter drainage

Abdominal paracentesis evacuation group

ACTIVE COMPARATOR

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

Procedure: Abdominal paracentesis evacuation

Interventions

Percutaneous catheter drainage 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.

Percutaneous catheter drainage group

Abdominal paracentesis evacuation PROCEDURE

Evacuation of peritoneal ascitic fluid using percutaneous catheters

Abdominal paracentesis evacuation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• fluid collections within two weeks of disease onset;
• single- or multi-organ failure;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Clinical Center Tuzla: lead

Related Publications (3)

• 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.

  PMID: 25320523 RESULT

• 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.

  PMID: 21478061 RESULT

• 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.

  PMID: 19444515 RESULT

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing; Sepsis; Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enver Zerem, MD.PhD

  University Clinical Center Tuzla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 7, 2016
• Study Start: January 1, 2010
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 28, 2016

Record last verified: 2016-10