Timing of Transmural Stent Removal in Necrotizing Pancreatitis

Acute Pancreatitis Clinical Trial

— TTSRNP  

Official title:

Timing of Transmural Stent Removal in Necrotizing Pancreatitis Undergoing Endoscopic Transmural Necrosectomy: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04963868
• Other study ID #: FAH of NCU
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: July 2021
• Source: The First Affiliated Hospital of Nanchang University
• Contact: Yin Zhu, PhD
• Phone: 86-791-88692507
• Email: zhuyin27[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Necrosis
• Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Walled-Off Necrosis

Intervention

Procedure:
• Stent removed by the novel strategy
The stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved;
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

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