Immediate necrosectomy vs. step-up approach after EUS-guided drainage of walled-off necrosis: a multicenter randomized controlled trial

JRCT ID: jRCT1032220055

Registered date:11/05/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Symptomatic walled-off necrosis (WON)
• Date of first enrollment: 11/05/2022
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Patients are randomised to two groups bleow.
Immediate necrosectomy group: Endoscopic necrosectomy is performed at the same session of EUS-PCD.
Step-up approach group: Step-up intervention is performed after the interval of 72-96 hours after EUS-PCD.Step-up interventions include additional stent placement, additional EUS-PCD, and additional percutaneous drainage.

Outcome(s)

• Primary Outcome: Tme to clinical success from randomization

Secondary Outcome

-Adverse event
-Mortality
-Technical success rate of initial EUS-PCD
-Incidence of biliary and gastrointestinal stricture
-Number and time of interventions
-Indwelling time of drainage of endoscopic and percutaneous drainage
-Success rate and procedure time for surgical procedures
-Hospital stay and ICU stay
-Duration of antibiotics administration
-Cost of interventions and hospital stay
-Recurence of WON
-Time to recurrence of WON
-Treatment duration of recurrent WON
-New onset of pseudocyst
-Treatment duration of new onset pseudocyst
-Incidence of new onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer
-The presence and time of medications for pancreatic exocrine insufficiency
-The presence and time of sarcopenia
-Morphological change of pancreas

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Patients with WON accoring to the revised Atlanta classification
-The long axis of WON is 4 cm or larger
-At least one of four conditions; signs of infection, Gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
-Patients who need drainage of WON
-Age of 18 years or older
-Patients or their representative provide informed consent
-Patients who visited or are hospitalized to the participating institutions

Exclude criteria

-WON inaccessible by EUS-guided approach
-WON with an indwelling AXIOS
-Severe coagulopathy; Platelet count <50,000/mm3 or PT-INR>1,5
-Patients on antithrombotic agents which are unable to be stopped or modified according to the guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment
-Patients who cannot tolerate endoscopic procedures safely
-Pregnancy
-Patients who are conidered as inappropriate for inclusion to the study

Related Information

• Primary Sponsor: Nakai Yousuke