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.
Over the last decade, approaches to managing necrotizing pancreatitis have evolved from open surgery to a minimally invasive approach due to the efficacy and lower morbidity and mortality rates of the latter technique. As one of minimally invasive approaches, endoscopic step-up approach, with transmural drainage whenever feasible and subsequent necrosectomy as required, was first described in 1996 and has evolved to first-line therapy for symptomatic necrotizing pancreatitis. However,The exact timing of transmural stent removal has not been well studied. The conventional strategy for stent removal in the published guidelines has been that patients should undergo follow-up imaging and stent removal at 4-8 weeks if walled-off necrosis has resolved. Here, we introduced a novel strategy in which the stents were removed during the last necrosectomy when the endpoint of endoscopic transmural necrosectomy was achieved, that was, the necrotic tissue was nearly completely removed, and the pink granulation tissue lining the wall was uncovered. Compared to the conventional strategy, the novel strategy avoided one endoscopy procedure. The present study is the first prospective, open-label, randomized controlled study to investigate the efficacy and safety of the novel strategy. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
The stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved;
The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image.
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The incidence of composite complications
The composite complications included new-onset organ failure or systemic complications、new-onset infectious pancreatic necrosis、abdominal or gastrointestinal bleeding, intestinal fistula, stent occlusion and stent migration.
Time frame: 3 months
The incidence of technical success
Technical success was defined by stent removed successfully.
Time frame: 3 months
The incidence of clinical success
Clinical success was defined as nearly completely resolution or \<2 cm of collection assessed by image at the three-month follow-up without additional open surgery or death.
Time frame: 3 months
The number of endoscopic transmural necrosectomy sessions
Total sessions of patients undergoing endoscopic transmural necrosectomy.
Time frame: 3 months
The number of additional endoscopic transmural necrosectomy sessions after stent removal
Additional sessions of patients undergoing endoscopic transmural necrosectomy. after stent removal.
Time frame: 3 months
Length of stent placement
The duration time from stent placement to stent removal.
Time frame: 3 months
The incidence of open surgery
The incidence of patients needing open surgery after minimally invasive treatment.
Time frame: 3 months
All-cause mortality
The mortality whatever the cause is.
Time frame: 3 months
Length of hospital stay
The length of hospital stay due to necrotizing pancreatitis.
Time frame: 3 months
The incidence of readmission
The incidence of readmission after index discharge due to pancreatitis related problems.
Time frame: 12 months
The hospital cost
The hospital cost during hospitalization.
Time frame: 3 months
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