Active clinical trials for "Pancreatitis, Acute Necrotizing"

The goal of this clinical trial is to compare a conventional endoscopic step-up approach with an accelerated treatment algorithm using direct endoscopic necrosectomy in patients with acute necrotizing pancreatitis and walled of necroses exceeding a diameter of 15 cm. It will be investigated whether an aggressive treatment algorithm instead of a classical step-up approach will shorten the length of stay in the hospital and also reduce the mortality in patients treated for large walled off necroses.

Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.

Walled-off pancreatic necrosis (WON) is associated with a mortality of 20-30%. The current evidence supports a minimally invasive drainage approach to infected WON. The current suggested approach in international guidelines is the endoscopic step-up approach. However, recent evidence from large national cohorts support the use of direct endoscopic necrosectomy (DEN) at the time of stent placement, resulting in earlier resolution of WON and less number of necrosectomies. This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.

Acute pancreatitis is one of the most common diagnoses made in gastroenterology wards worldwide which causes a great deal of pain and expense along with fatal complications. Approximately, 10-20% of patients progress to necrotizing pancreatitis that result in significant morbidity and mortality. Initial conservative management may be feasible in necrotizing pancreatitis, however the majority of patients with infected necrosis or persistent symptoms will eventually require a drainage procedure. Drainage procedures for necrotizing pancreatitis include open surgery, minimally invasive surgery, percutaneous drainage, and endoscopic drainage. In the recent years, minimally invasive approaches have largely replaced open surgical necrosectomy. Endoscopic drainage of walled off pancreatic necrosis involves creation of a transmural fistula between the enteral lumen and WOPN cavity with stent placement under endoscopic ultrasound (EUS) guidance. Furthermore, direct endoscopic necrosectomy can be performed through the fistula track. The best timing for endoscopic necrosectomy is not yet defined. A recent retrospective study suggested that immediate necrosectomy after stent placement results in earlier resolution of WOPN with fewer sessions of endoscopic necrosectomy. The aim of this study is to compare immediate vs. on-demand endoscopic necrosectomy in patients with infected WOPN who undergo EUS-guided transmural drainage of WOPN.

The LPN procedure is performed under general anesthesia. The transperitoneal access to peripancreatic space is via the gastro-colic ligament and greater omentum, effusion and pus is removed by laparoscopic forceps and suction. Laparoscopic cholecystectomy (LC) is performed during the LPN procedure on patients with indication. The NPN procedure is followed by the standard retroperitoneal approach. After the catheter is exchanged over a guide wire and serially dilated up from 6F to 24F followed by Seldinger technique, the access track to the necrotic cavity is established. A nephroscope is inserted into the cavity through the track for debridement. Using forceps and suction, the peripancreatic solid necrotic tissue and pus is grasped and removed. A large-bore irrigating drain is left in the cavity, with continuous irrigation by warm normal saline solution at a rate of 100-125 ml/h after surgery.

The open abdomen can occur as a result of various diseases. After infections of the abdomen, compartment syndromes or traumata, it is essential for survival (1). This condition of the open abdomen lasts from days to months. Within a very short time, the fascia and abdominal wall structures retract in such a way that direct abdominal closure is often impossible. In addition, there is a pronounced intraabdominal oedema, which additionally increases the space required by the abdominal organs. Therefore, it is clinically indispensable to increase the space of the intraabdominal organs in this life-threatening situation. After the laparotomy (opening of the abdomen) has been performed, it is therefore not closed. However, the natural traction on the abdominal wall, in particular on the fascia, the attached musculature as well as skin and subcutis, no longer exists in this situation. As a result, these structures retract over the period of the existing laparostoma. In the present study, the CE-certified medical device Fasciotens Abdomen will be used to prove the functionality of this device and the user feasibility. The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. The possibility to apply a traction to the fascia from the moment of opening the abdomen without reducing the intraabdominal space is absolutely new and the rationale of this technique. The objective of this study is to prove the obvious prevention of fascial retraction through the Fasciotens Abdomen device.

This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

Although metal stents have been widely used in the endoscopic step-up approach for necrotizing pancreatitis, the exact timing of transmural stent removal has not been well studied. In this prospective, open-label, randomized controlled study, we recruited and enrolled consecutive patients with necrotizing pancreatitis undergoing endoscopic transmural necrosectomy. Eligible participants were randomly assigned to case group (a novel strategy in which the stents were removed during the last necrosectomy when the necrosectomy endpoint was achieved) and control group (the conventional strategy in which the stents were removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by imaging). The primary endpoint was the incidence of composite complications within three months of enrollment.

Regulatory Context The CNEDiMTS makes the renewal of registration conditional on the transmission of the results of a well-conducted prospective study, carried out with Hot AXIOS, the objective of which is to evaluate the interest of this device in real conditions of use with regard to effectiveness and complications after a minimum follow-up of 3 months. Operators are trained in the use of the equipment (practice on ex-vivo model and/or prior stent placement) and undertake to comply with the rules and formalities of use. Primary efficacy objective : To evaluate the efficacy of endoscopic trans digestive drainage after use of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic) at 3 months. Secondary Objectives : Assessment of the following elements : Morbidity (complication rates) and mortality per- and post-procedure Recurrence rate of pancreatic collection Evolution of the quality of life questionnaire (SQ5D5L) Technical success rate of prosthesis placement and removal success rate of the prosthesis Search for factors predictive of clinical success of endoscopic pancreatic drainage with the Hot Axios prosthesis. Study design Non-interventional/observational (RIPH 3 type), multi-center, prospective study with consecutive inclusions evaluating the Hot AXIOS® prosthetic device. Non-inclusion registry A minimum amount of information will be collected anonymously, including sex, age, indication of drainage and reason for non-inclusion (e.g. refusal of the patient, of the investigator for impossibility of following the patient in the centre or other reasons to be specified). Generic information will be affixed in each centre participating in the study indicating: "In application of the provisions of the Data Protection Act, general information on the possibility that personal data may be used for research purposes must be provided in any establishment or centre where prevention, diagnosis and care activities are carried out". This must be exhaustive and rigorously maintained. Equipment used in endoscopy Hot AXIOS™ - self-expanding metal prosthesis with a lumen diameter of 6 to 20 mm and collar length of 8 and 10 mm or any future similar device marketed under the same name at the time of the study. Technique Insertion of the material under echo-endoscopic control -- possible but not systematic dilatation -- guide wire with hydrophilic tip - Puncture and release under echo-endoscopic control according to the centre's usual practice. Registration The data will be collected anonymously in an electronic computer database using eCRFs. Statistical analysis The evaluation of the clinical success of endoscopic pancreatic necrosectomy with metallic prosthesis will first consist in describing its efficacy according to the criteria described above. Analysis plan : The statistical analysis will first include a description of the study population with the number of patients falling under the indication and treated with the Hot AXIOS system at the recruiting centers (source population), the number of eligible patients who consented to participate in the study, the number of patients included (study population), the number of subjects who made each visit and were analyzed, premature exits (deaths, lost to follow-up) will be reported and described in the form of a flow chart.

Patients with the diagnosis of acute necrotizing pancreatitis (ANP) present with a wide spectrum of severity. These patients frequently require intensive care management. According to the revised Atlanta classification (2012), acute pancreatitis is divided into distinct subtypes, based on the presence or absence of necrosis. The mortality rates for sterile necrosis though comparatively low (5%-10%), but superinfection of the necrotic pancreas and peri-pancreatic tissue/ fluid collections increases the mortality rate considerably (up to one-third). The most common organisms isolated from the infected pancreatic necrosum are gram-negative bacteria mainly Escherichia coli and Klebsiella pneumoniae followed by gram-positive bacteria; however, with the increased use of antibiotic therapies in the ICU, the incidence of pancreatic fungal infections is also on a rise. Traditionally, critically ill patients have been considered immunocompetent but the immunomodulatory effects of sepsis may lead to reactivation of dormant viral infections. In recent years, Cytomegalovirus (CMV) reactivation in critically ill patients has been recognized with as high as 71% incidence with associated higher mortality, organ failure rates, duration of mechanical ventilation, nosocomial infections, and ICU length of stay. CMV reactivation had been studied in various cohorts in the ICU population, such as acute respiratory distress syndrome (ARDS) and septic shock exhibiting their impact on mortality. However, currently, no study is available investigating the role of CMV reactivation in patients with acute necrotizing pancreatitis. Therefore, the investigators aimed to study the prevalence of CMV reactivation and its viral load kinetics in critically ill patients with acute necrotizing pancreatitis.