An interventional study of Immediate necrosectomy and Step-up approach in Pancreatic Fluid Collection, Walled-off Necrosis and Pancreatitis, Acute Necrotizing, sponsored by Tokyo University. Recruiting at 21 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Tokyo University · Not applicable, Interventional, and Treatment
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.
Pancreatic fluid collection is a late complication of severe acute pancreatitis. According to the revised Atlanta classification, walled-off necrosis (WON) is defined as an encapsulated collection of necrotic tissue that is observed after four weeks of the onset of acute pancreatitis. Infected WON is associated with high morbidity and mortality; therefore, an appropriate treatment, including antibiotics and drainage, is mandatory. With the development of endoscopic equipment, endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality for infected WON. For patients who are refractory to EUS-guided drainage, endoscopic necrosectomy (EN) is a treatment option to facilitate direct removal of infected necrotic tissue within the WON. However, due to potentially lethal adverse events of EN, such as bleeding, perforation, and peritonitis, EN is usually withheld for several days after EUS-guided drainage. This strategy is known as "the step-up approach." Recently, with the accumulated evidence supporting the safety of EN, especially with the use of a dedicated lumen-apposing metal stent, it has been reported that EN immediately after EUS-guided drainage can shorten the treatment duration without increasing adverse events. Given these lines of evidence, the investigators hypothesized that immediate EN following EUS-guided drainage of WON might shorten time to clinical success compared to the step-up approach. To examine this hypothesis, the investigators planned to conduct a multicenter randomized controlled trial comparing treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
74 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 47 interventional studies indexed under Pancreatitis, Acute Necrotizing.
Browse Pancreatitis, Acute Necrotizing studies →Tokyo University is the lead sponsor of 34 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success.
Procedure: Immediate necrosectomy
Step-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment.
Procedure: Step-up approach
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the immediate necrosectomy group, endoscopic necrosectomy (EN) will be performed in the same session of EUS-guided drainage using a gastroscope. The endoscope is inserted into the WON cavity through the LAMS, and necrotic tissue is removed using biopsy forceps, snare, or basket catheter. The EN procedures will be repeated until clinical improvement.
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the step-up approach group, an additional interventional procedure will be withheld for 72-96 hours after initial EUS-guided drainage. In cases without clinical improvement after 72-96 hours, additional drainage will be permitted, which includes increasing the number of stents, additional EUS-guided drainage, and performing percutaneous drainage (step-up treatment). Insufficient improvement even after two times of step-up treatment allows subsequent endoscopic necrosectomy (EN).
Time to clinical success from randomization
Clinical success is defined as 1) a decrease in the WON size to 3 cm or less and 2) an improvement of more than two out of the three following inflammatory markers; body temperature, white blood cell count, and C-reactive protein.
Time frame: Six months
Adverse events
All procedure-related adverse events including bleeding, perforation, peritonitis, etc.
Time frame: Five years
Mortality
Mortality from any cause
Time frame: Five years
Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage)
Successful placement of EUS-guided drainage including a lumen-apposing metal stent and plastic stents
Time frame: One day
Incidence of biliary and gastrointestinal stricture
Inflammatory-induced obstruction of bile duct and gastrointestinal tract
Time frame: Five years
Number and time of interventions
Total number of interventions and total procedure time
Time frame: Six months
Indwelling time of endoscopic and percutaneous drainage
Indwelling period of stents and drainage tube
Time frame: Six months
Success rate and operation time of surgical procedures
Success rate of surgeries associated with WON and total operation time
Time frame: Six months
Hospital stay and ICU stay
Total hospitalization days and total ICU stay
Time frame: Six months
Duration of antibiotics administration
Total administration days of antibiotics
Time frame: Six months
Cost of interventions and hospital stay
Total cost of interventions and total cost of hospitalization
Time frame: Six months
Recurrence of WON
Incidence of recurrence of WON
Time frame: Five years
Time to recurrence of WON
Time from clinical success to recurrence of WON
Time frame: Five years
Treatment duration of recurrent WON
Total treatment period for recurrent WON
Time frame: Five years
New onset of pseudocyst
Incidence of new-onset pancreatic pseudocyst
Time frame: Five years
Treatment duration of new onset pseudocyst
Total treatment period for new-onset pancreatic pseudocyst
Time frame: Five years
Incidence of new onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer
New-onset diabetes mellitus, pancreatic cancer, and clinical symptoms associated with pancreatic exocrine insufficiency, such as steatorrhea , constipation, diarrhea, maldigestion, flatulence, and tenesmus
Time frame: Five years
The presence and timing of medications for pancreatic exocrine insufficiency
The start of medications for pancreatic exocrine insufficiency and the date
Time frame: Five years
The presence and timing of sarcopenia
The presence of sarcopenia and the date of diagnosis
Time frame: Five years
Morphological change of pancreas
Change in the morphology and the volume of pancreas
Time frame: Five years
Plan to share: No
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