Acute PancreatitisTTSRNPNCT04963868
Timing of Transmural Stent Removal in Necrotizing Pancreatitis
A study testing Stent removed by the novel strategy and Stent removed by the conventional strategy in people with Acute Pancreatitis and Necrotizing Pancreatitis, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Necrotizing Pancreatitis, Walled-Off Necrosis
- What is being tested?
- Stent removed by the novel strategy and Stent removed by the conventional strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with necrotizing pancreatitis according to the 2012 Atlanta classification criteria;
- Patients aged between 18 and 65 years;
- Patients who signed the informed consent;
Who cannot join
- Patients without transmural stent placement;
- Patients with transmural plastic stent not metal stent placement before enrollment;
- Patients who underwent endoscopic transmural necrosectomy in other hospitals before admission;
- Patients complicated with chronic pancreatitis;
- Patients complicated with pancreatic tumor;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yin Zhu, PhD, 86-791-88692507, zhuyin27@sina.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Stent removed by the novel strategy, Stent removed by the conventional strategy
- Keywords
- Necrotizing pancreatitis, Endoscopic transmural necrosectomy, Lumen-apposing metal stent
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent removed by the novel strategyProcedure or surgery
The stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved；
Stent removed by the conventional strategyProcedure or surgery
The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image.
| Study group | Role | What they receive |
|---|---|---|
| The novel strategy group | Experimental | The stents were removed during the last necrosectomy when the endpoint of necrosectomy was achieved Receives: Procedure: Stent removed by the novel strategy |
| The conventional strategy group | Active comparator | The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image Receives: Procedure: Stent removed by the conventional strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (10)
The incidence of technical success
Technical success was defined by stent removed successfully.
Measured: 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.
Measured: 3 months
The number of endoscopic transmural necrosectomy sessions
Total sessions of patients undergoing endoscopic transmural necrosectomy.
Measured: 3 months
The number of additional endoscopic transmural necrosectomy sessions after stent removal
Additional sessions of patients undergoing endoscopic transmural necrosectomy. after stent removal.
Measured: 3 months
Length of stent placement
The duration time from stent placement to stent removal.
Measured: 3 months
The incidence of open surgery
The incidence of patients needing open surgery after minimally invasive treatment.
Measured: 3 months
All-cause mortality
The mortality whatever the cause is.
Measured: 3 months
Length of hospital stay
The length of hospital stay due to necrotizing pancreatitis.
Measured: 3 months
The incidence of readmission
The incidence of readmission after index discharge due to pancreatitis related problems.
Measured: 12 months
The hospital cost
The hospital cost during hospitalization.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyu Luo, The First Affiliated Hospital of Nanchang University
- Investigators
- Yin Zhu, PhD, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963868
- Sponsor's protocol ID
- FAH of NCU
- Acronym
- TTSRNP
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Transmural Stent Removal in Necrotizing Pancreatitis Undergoing Endoscopic Transmural Necrosectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04963868
- Acronym / sponsor ID
- TTSRNP / FAH of NCU
- Keywords
- Necrotizing pancreatitis, Endoscopic transmural necrosectomy, Lumen-apposing metal stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The novel strategy group | Experimental | Procedure: Stent removed by the novel strategyThe stents were removed during the last necrosectomy when the endpoint of necrosectomy was achieved |
| The conventional strategy group | Active comparator | Procedure: Stent removed by the conventional strategyThe stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with necrotizing pancreatitis according to the 2012 Atlanta classification criteria;
- Patients aged between 18 and 65 years;
- Patients who signed the informed consent;
Key exclusion criteria (6 listed)
- Patients without transmural stent placement;
- Patients with transmural plastic stent not metal stent placement before enrollment;
- Patients who underwent endoscopic transmural necrosectomy in other hospitals before admission;
- Patients complicated with chronic pancreatitis;
- Patients complicated with pancreatic tumor;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent removed by the novel strategyThe stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved； | Procedure or surgery | The novel strategy group |
| Stent removed by the conventional strategyThe stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image. | Procedure or surgery | The conventional strategy group |
Primary outcome
The incidence of composite complications
Time frame: 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.
10 secondary outcomes
The incidence of technical success
Time frame: 3 months
The incidence of clinical success
Time frame: 3 months
The number of endoscopic transmural necrosectomy sessions
Time frame: 3 months
The number of additional endoscopic transmural necrosectomy sessions after stent removal
Time frame: 3 months
Length of stent placement
Time frame: 3 months
The incidence of open surgery
Time frame: 3 months
All-cause mortality
Time frame: 3 months
Length of hospital stay
Time frame: 3 months
The incidence of readmission
Time frame: 12 months
The hospital cost
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin Zhu, PhD principal investigator
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent removed by the novel strategy and Stent removed by the conventional strategy in people with Acute Pancreatitis and Necrotizing Pancreatitis, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin Zhu, PhD (86-791-88692507, zhuyin27@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of composite complications (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.