Timing of Transmural Stent Removal in Necrotizing Pancreatitis

Not Applicable

Not yet recruiting

• Conditions: Walled-Off Necrosis; Necrotizing Pancreatitis; Acute Pancreatitis
• Interventions: Procedure: Stent removed by the novel strategy; Procedure: Stent removed by the conventional strategy

• Registration Number: NCT04963868
• Lead Sponsor: The First Affiliated Hospital of Nanchang University

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.

Study Timeline

• Study First Submitted: 2021-06-21
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15
• Study Start: 2022-01-01
• Primary Completion: 2024-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

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;

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The novel strategy group	Stent removed by the novel strategy	The stents were removed during the last necrosectomy when the endpoint of necrosectomy was achieved
The conventional strategy group	Stent removed by the conventional strategy	The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image

Primary Outcome Measures

Name	Time	Method
The incidence of composite complications	3 months	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.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	3 months	The mortality whatever the cause is.
Length of stent placement	3 months	The duration time from stent placement to stent removal.
The incidence of technical success	3 months	Technical success was defined by stent removed successfully.
The number of endoscopic transmural necrosectomy sessions	3 months	Total sessions of patients undergoing endoscopic transmural necrosectomy.
Length of hospital stay	3 months	The length of hospital stay due to necrotizing pancreatitis.
The incidence of clinical success	3 months	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.
The number of additional endoscopic transmural necrosectomy sessions after stent removal	3 months	Additional sessions of patients undergoing endoscopic transmural necrosectomy. after stent removal.
The incidence of open surgery	3 months	The incidence of patients needing open surgery after minimally invasive treatment.
The incidence of readmission	12 months	The incidence of readmission after index discharge due to pancreatitis related problems.
The hospital cost	3 months	The hospital cost during hospitalization.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China