Clinical trial NCT04963868: Timing of Transmural Stent Removal in Necrotizing Pancreatitis
Official title: Timing of Transmural Stent Removal in Necrotizing Pancreatitis Undergoing Endoscopic Transmural Necrosectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Pancreatitis
Necrotizing Pancreatitis
Walled-Off Necrosis
Keywords: Necrotizing pancreatitis
Endoscopic transmural necrosectomy
Lumen-apposing metal stent
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with necrotizing pancreatitis according to the 2012 Atlanta classification criteria;
2. Patients aged between 18 and 65 years;
3. Patients who signed the informed consent;

Exclusion Criteria:

1. Patients without transmural stent placement;
2. Patients with transmural plastic stent not metal stent placement before enrollment;
3. Patients who underwent endoscopic transmural necrosectomy in other hospitals before admission;
4. Patients complicated with chronic pancreatitis;
5. Patients complicated with pancreatic tumor;
6. Pregnant or lactating women.

Primary outcomes:
measure: The incidence of composite complications
timeFrame: 3 months
Secondary outcomes:
measure: The incidence of technical success
timeFrame: 3 months
measure: The incidence of clinical success
timeFrame: 3 months
measure: The number of endoscopic transmural necrosectomy sessions
timeFrame: 3 months
measure: The number of additional endoscopic transmural necrosectomy sessions after stent removal
timeFrame: 3 months
measure: Length of stent placement
timeFrame: 3 months
measure: The incidence of open surgery
timeFrame: 3 months
measure: All-cause mortality
timeFrame: 3 months
measure: Length of hospital stay
timeFrame: 3 months
measure: The incidence of readmission
timeFrame: 12 months
measure: The hospital cost
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: Yin Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
References: