Timing of Transmural Stent Removal in Necrotizing Pancreatitis (TTSRNP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Pancreatitis; Necrotizing Pancreatitis; Walled-Off Necrosis
• Intervention / Treatment: Procedure: Stent removed by the novel strategy; Procedure: Stent removed by the conventional strategy

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 Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yin Zhu, PhD; Phone Number: 86-791-88692507; Email: zhuyin27@sina.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
      • Contact: Yin Zhu, PhD; Phone Number: 86-791-88692507; Email: zhuyin27@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The novel strategy group; The stents were removed during the last necrosectomy when the endpoint of necrosectomy was achieved	Procedure: Stent removed by the novel strategy; The stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved；
Active Comparator: The conventional strategy group; The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Nanchang University
• Investigators: Principal Investigator: Yin Zhu, PhD, The First Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Necrotizing pancreatitis; Lumen-apposing metal stent; Endoscopic transmural necrosectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pancreatic Diseases; Necrosis; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: FAH of NCU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No