Percutaneous Continuous Irrigation Combined With Transgastric Necrosectomy usingLAMS in Treatment of SAP

NCT05508828 | Completed DMC

• 1 other identifier: DRUMPCILAMS
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Severe acute pancreatitis (SAP) is the most severe form of acute pancreatitis (AP) and Infection of pancreatic necrosis (IPN) have shown to be one of the decisive factors defining the severity of illness. Minimally invasive techniques including endoscopy, laparoscopy, retroperitoneal approaches, etc., have recently been widely used for debridement because the procedure can further reduces surgical stress and performed not require general anesthesia, thereby reducing complications. Studies have shown that endoscopic transgastric necrosectomy can significantly reduced the proinflammatory response, complications, and hospital stay. Despite these advantages, there are some limitations with this approach. First, transgastric necrosectomy should be performed as late (about 4 weeks) in the course of the disease as possible to allow necrosis to wrap, since early debridement may result in a higher patient fatality rate. However, patients with SAP are often in a severely ill state due to sepsis or MODS at an early stage, which causes them unable to adhere to necrotic tissue encapsulation by conservative treatment. Second, the ideal patient to select for this approach has necrosis confined in the vicinity of gastroduodenal location. Last, up to 27% of IPN patients require additional percutaneous catheter drainage (PCD) after undergoing endoscopic transluminal therapy. This may be explained by the fact that dissemination of necrosis, digestive enzymes and inflammatory mediators from the necrotic tissue lumen to other parts of the abdominal cavity during endoscopic procedures. Percutaneous catheter drainage (PCD) has always been the principal treatment measure for patients with AP at early stage (\< 4 weeks) or those with collections or necrosis extending into deeper anatomical planes. Irrigation through peripancreatic drainage placed after open laparotomy has been the standard treatment for patients with AP who had undergone surgical necrosectomy. However, this proactive approach has not been widely used in the setting of PCD. To adequate drainage and removal of necrosis, an early percutaneous continuous irrigation assisted vacuum drainage in combination with subsequent endoscopic transgastric necrosectomy which has not been reported so far was applied in critically ill patients with SAP.

Conditions

Severe Acute Pancreatitis; Pancreatic Necrosis

Outcome Measures

Primary Outcomes (1)

• mortality

  28day-mortality

  Day28 after enrollment

Secondary Outcomes (2)

• PCD

  From the first catheter placement to total catheter removal

• endoscopic procedures

  through study completion, an average of 3 months

Study Arms (1)

The study group

We retrospectively analysis of 8 consecutive patients with SAP and IPN. SAP was diagnosed with persistent organ failure \>48h. IPN was considered when the following situations occur: ≥38.5℃; increasing WBC, CRP or procalcitonin; rapid clinical deterioration; signs of gas was present in areas of necrosis.

Procedure: Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric Necrosectomy

Interventions

Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric Necrosectomy PROCEDURE

All patients with SAP were given contrast enhanced CT scan within 48 hours after admission to identify the location and range of the necrosis. If the patient's condition progressively worsened, a multifunctional irrigation-assisted vacuum drainage tube was placed by the CT-guided Seldinger technique in each of the necrosis cavity. Subsequently, transgastric necrosectomy were performed by one or two experienced endoscopist under conscious sedation. The procedure was repeated until all loosely adherent necrotic material were cleared and replaced by granulation tissue. Percutaneous irrigation was stopped and replace with simple drainage if the patient's condition continues to improved and the cavity confirmed by CT was resolution. If the drainage volume was less than 10 mL/day for 3 consecutive days, clamp the drainage tube and remove it finally.

The study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with SAP and IPN;SAP was diagnosed according to the revised Atlanta classification, which defined simultaneous persistent single or multiple organ failure \>48h;IPN was considered when the following situations occur: persistent fever ≥38.5℃; increasing blood white blood cells (WBC), C-reactive protein (CRP) or procalcitonin; rapid deterioration of clinical deterioration; signs of gas was present in areas of necrosis. IPN is confirmed when the patient undergoes fine needle aspiration and the culture was positive.

You may qualify if:

• Diagnosed with SAP
• Concurrent IPN

You may not qualify if:

• Age \<18 years or \> 80 years
• Patients or family members disagreed with this study

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Related Publications (6)

• van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG; Dutch Pancreatitis Study Group. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502. doi: 10.1056/NEJMoa0908821.

  PMID: 20410514 RESULT

• Lee JK, Kwak KK, Park JK, Yoon WJ, Lee SH, Ryu JK, Kim YT, Yoon YB. The efficacy of nonsurgical treatment of infected pancreatic necrosis. Pancreas. 2007 May;34(4):399-404. doi: 10.1097/MPA.0b013e318043c0b1.

  PMID: 17446837 RESULT

• Ross A, Gluck M, Irani S, Hauptmann E, Fotoohi M, Siegal J, Robinson D, Crane R, Kozarek R. Combined endoscopic and percutaneous drainage of organized pancreatic necrosis. Gastrointest Endosc. 2010 Jan;71(1):79-84. doi: 10.1016/j.gie.2009.06.037. Epub 2009 Oct 27.

  PMID: 19863956 RESULT

• Sahar N, Kozarek R, Kanji ZS, Ross AS, Gluck M, Gan SI, Larsen M, Irani S. Do lumen-apposing metal stents (LAMS) improve treatment outcomes of walled-off pancreatic necrosis over plastic stents using dual-modality drainage? Endosc Int Open. 2017 Nov;5(11):E1052-E1059. doi: 10.1055/s-0043-111794. Epub 2017 Oct 26.

  PMID: 29090245 RESULT

• Jagielski M, Smoczynski M, Studniarek M, Adrych K. Endoscopic drainage combined with percutaneous drainage in treatment of walled-off pancreatic necrosis - a single-center experience. Prz Gastroenterol. 2018;13(2):137-142. doi: 10.5114/pg.2018.72604. Epub 2018 Jan 5.

  PMID: 30002773 RESULT

• Zhang B, Gao T, Wang Y, Zhu H, Liu S, Chen M, Yu W, Zhu Z. A novel mini-invasive step-up approach for the treatment of severe acute pancreatitis with extensive infected necrosis: A single center case series study. Medicine (Baltimore). 2023 Mar 17;102(11):e33288. doi: 10.1097/MD.0000000000033288.

  PMID: 36930105 DERIVED

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Wenkui Yu, Ph.D

  Study concept and study design

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 19, 2022
• Study Start: January 1, 2019
• Primary Completion: May 9, 2022
• Study Completion: August 14, 2022
• Last Updated: August 19, 2022

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)