Walled-off NecrosisNCT04876235
A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis
A study testing endoscopic ultrasound, lumen-apposing metal stent and double-pigtail plastic stents in people with Walled-off Necrosis, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Walled-off Necrosis
- What is being tested?
- endoscopic ultrasound, lumen-apposing metal stent and double-pigtail plastic stents
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtention of a written informed consent
- According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON
- The diameter of WON ≥6cm
- Patient capable of fill in the quality of life questionnaire
- The distance between the EUS-probe and WON was < 1 cm.
Who cannot join
- No written informed consent
- pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors
- pancreatic pseudocyst
- WON too far from the stomach and duodenum to perform endoscopic drainage
- Serious abnormalities in liver and kidney function and coagulation function
- Pregnant, parturient or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Double-pigtail Plastic Versus Lumen-apposing Metal Stents for Transmural Drainage of Walled-off Necrosis
Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.
Read the detailed description
According to the revised Atlanta classification, pancreatic fluid collections (PFCs) include acute peripancreatic fluid collections(APFCs) and acute necrotic collections(ANCs), which, over time, turn into pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON). Drainage of these PP and WON is required when they increase in size and become infected or become symptomatic.
Traditionally, WON has been managed surgically, however, surgical necrosectomy is associated with substantial morbidity and mortality, particularly when pursued early. In recent years, with the development of minimally invasive techniques, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON).
Double-pigtail plastic stents(DPPS) is the earliest stent used for WON drainage in ultrasound endoscopy, however, These stents are limited by their small diameter leading to increased risk of stent obstruction. Recently, lumen-apposing metal stents (LAMS) have been increasingly used because of the advantage of better lumen apposition and wider diameter, improving access for endoscopic debridement. However, more adverse events(AEs) such as bleeding have been reported.
This article aims to compare the efficacy and safety of DPPS and LAMS in the treatment of Walled-off necrosis
- Conditions
- Walled-off Necrosis
- Being tested
- endoscopic ultrasound, lumen-apposing metal stent, double-pigtail plastic stents
- Keywords
- endoscopic ultrasound guided drainage, Lumen-apposing metal stent, double-pigtail plastic stents, Walled-off necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasoundProcedure or surgery
All patients were implanted with stents（DPPS or LAMS）under the EUS
lumen-apposing metal stentDevice
In the LAMS group, patients were stented with LAMS
double-pigtail plastic stentsDevice
In the DPPS group, patients were stented with DPPS
| Study group | Role | What they receive |
|---|---|---|
| LAMS group | Experimental | place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary Receives: Procedure: endoscopic ultrasound; Device: lumen-apposing metal stent |
| DPPS group | Active comparator | Place DPPS under endoscopic ultrasound. When required, DEN was performed once the cystogastrostomy/duodenostomy tract had matured. This was done by first removing the stents followed by dilation of the tract with a radial expansion balloon and insertion of a forward viewing gastroscope through the tract for DEN Receives: Procedure: endoscopic ultrasound; Device: double-pigtail plastic stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success (clinical improvement and resolution of WON)
compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis
Measured: two months
Secondary outcomes (1)
Adverse Events
Number of participants with adverse events; type, frequency and intensity of adverse events
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 May 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Walled-off NecrosisStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Xiaofeng Zhang, M.S, Study director, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876235
- Sponsor's protocol ID
- 2021-03-221
- Status last verified
- Feb 2023
- First submitted
- 30 Apr 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Double-pigtail Plastic Versus Lumen-apposing Metal Stents for Transmural Drainage of Walled-off Necrosis
- ClinicalTrials.gov ID
- NCT04876235
- Acronym / sponsor ID
- 2021-03-221
- Conditions
- Walled-off Necrosis
- Keywords
- endoscopic ultrasound guided drainage, Lumen-apposing metal stent, double-pigtail plastic stents, Walled-off necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 May 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.
Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.
Detailed description
According to the revised Atlanta classification, pancreatic fluid collections (PFCs) include acute peripancreatic fluid collections(APFCs) and acute necrotic collections(ANCs), which, over time, turn into pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON). Drainage of these PP and WON is required when they increase in size and become infected or become symptomatic.
Traditionally, WON has been managed surgically, however, surgical necrosectomy is associated with substantial morbidity and mortality, particularly when pursued early. In recent years, with the development of minimally invasive techniques, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON).
Double-pigtail plastic stents(DPPS) is the earliest stent used for WON drainage in ultrasound endoscopy, however, These stents are limited by their small diameter leading to increased risk of stent obstruction. Recently, lumen-apposing metal stents (LAMS) have been increasingly used because of the advantage of better lumen apposition and wider diameter, improving access for endoscopic debridement. However, more adverse events(AEs) such as bleeding have been reported.
This article aims to compare the efficacy and safety of DPPS and LAMS in the treatment of Walled-off necrosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAMS group | Experimental | Procedure: endoscopic ultrasound, Device: lumen-apposing metal stentplace LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary |
| DPPS group | Active comparator | Procedure: endoscopic ultrasound, Device: double-pigtail plastic stentsPlace DPPS under endoscopic ultrasound. When required, DEN was performed once the cystogastrostomy/duodenostomy tract had matured. This was done by first removing the stents followed by dilation of the tract with a radial expansion balloon and insertion of a forward viewing gastroscope through the tract for DEN |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obtention of a written informed consent
- According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON
- The diameter of WON ≥6cm
- Patient capable of fill in the quality of life questionnaire
- The distance between the EUS-probe and WON was < 1 cm.
Key exclusion criteria (6 listed)
- No written informed consent
- pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors
- pancreatic pseudocyst
- WON too far from the stomach and duodenum to perform endoscopic drainage
- Serious abnormalities in liver and kidney function and coagulation function
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 |
|---|---|---|
| endoscopic ultrasoundAll patients were implanted with stents（DPPS or LAMS）under the EUS | Procedure or surgery | DPPS group, LAMS group |
| lumen-apposing metal stentIn the LAMS group, patients were stented with LAMS | Device | LAMS group |
| double-pigtail plastic stentsIn the DPPS group, patients were stented with DPPS | Device | DPPS group |
Primary outcome
clinical success (clinical improvement and resolution of WON)
Time frame: two months
compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis
1 secondary outcome
Adverse Events
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Walled-off Necrosis
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Recruiting
The Effect of Proton Pump Inhibitors(PPIs) on Endoscopic Treatment of Walled-off Necrosis (WON)
Pancreatic Walled-off Necrosis
Recruiting
Necrosectomy With Cryotechnology for Accelerated Removal
Pancreatic Necrosis, Acute Pancreatitis
Recruiting
Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis
Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP)
Recruiting
Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis
Acute Necrotizing Pancreatitis
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.
Xiaofeng Zhang, M.S study director
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasound, lumen-apposing metal stent and double-pigtail plastic stents in people with Walled-off Necrosis, run by First People's Hospital of Hangzhou 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 5 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: finished, as of the sponsor's last update on 21 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical success (clinical improvement and resolution of WON) (time frame: two 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 21 Feb 2023.