Necrosis of PancreasMISERNCT02084537
Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
A study testing Endoscopic treatment and Minimally invasive surgical necrosectomy in people with Necrosis of Pancreas and Infected Pancreatic Necrosis, run by AdventHealth at 1 site in United States.
Trial summary
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrosis of Pancreas, Infected Pancreatic Necrosis
- What is being tested?
- Endoscopic treatment and Minimally invasive surgical necrosectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 30 Sep 2018
- 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
- Necrotic collection
- Infected (suspected and confirmed): clinical signs of infection (septic, positive cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents
- Necrotic collection is within 15mm of the lumen of the gastrointestinal tract.
- 18 years and older
- Informed consent obtained from the patient or their medical representative.
- Medically fit for general anesthetic
- Collection amenable to either endoscopic or minimally invasive surgical necrosectomy and drainage.
Who cannot join
- <18 years old
- Unable to obtain informed consent from the patient or their medical representative.
- Medically unfit for general anesthesia
- Pregnant
- Necrotic collection not accessible by either or both techniques
- The collection is >15mm from the lumen of the gastrointestinal tract.
Show all 12Show fewer
- Irreversible coagulopathy: International Normalized Ratio (INR) >1.5
- Irreversible thrombocytopenia: platelet count <50 x10^9/L
- Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
- Surgical or endoscopic necrosectomy or pseudocyst drainage has been performed within the preceding 12 months
- Necrotic collection secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury.
- Pre-existing percutaneous drain
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Hospital Center for Interventional Endoscopy
Orlando, Florida, 34786
About this study
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.
Read the detailed description
Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.
- Conditions
- Necrosis of Pancreas, Infected Pancreatic Necrosis
- Being tested
- Endoscopic treatment, Minimally invasive surgical necrosectomy
- Keywords
- symptomatic, infected, necrotic collection
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic treatmentProcedure or surgery
Also called Endoscopic cystogastrostomy, Endoscopic cystoduodenostomy, Endoscopic necrosectomy
Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.
Minimally invasive surgical necrosectomyProcedure or surgery
Also called Video-assisted retroperitoneal debridement (VARD), Laparoscopic cystogastrostomy with internal debridement
Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic treatment | Active comparator | Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7 French (Fr) double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed. Receives: Procedure: Endoscopic treatment |
| Minimally invasive surgical necrosectomy | Active comparator | Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement. Receives: Procedure: Minimally invasive surgical necrosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications
Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge
Measured: 6 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2017
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrosis of PancreasStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam S Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084537
- Sponsor's protocol ID
- 577235
- Acronym
- MISER
- Status last verified
- Feb 2019
- First submitted
- 10 Mar 2014
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bang JY, Arnoletti JP, Holt BA, Sutton B, Hasan MK, Navaneethan U, Feranec N, Wilcox CM, Tharian B, Hawes RH, Varadarajulu S. An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis. Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031. Epub 2018 Nov 16.
PubMed 30452918
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
- ClinicalTrials.gov ID
- NCT02084537
- Acronym / sponsor ID
- MISER / 577235
- Conditions
- Necrosis of Pancreas, Infected Pancreatic Necrosis
- Keywords
- symptomatic, infected, necrotic collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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.
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.
Detailed description
Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment | Active comparator | Procedure: Endoscopic treatmentTreated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7 French (Fr) double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed. |
| Minimally invasive surgical necrosectomy | Active comparator | Procedure: Minimally invasive surgical necrosectomyVideo-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Necrotic collection
- Necrotic collection is within 15mm of the lumen of the gastrointestinal tract.
- 18 years and older
- Informed consent obtained from the patient or their medical representative.
- Medically fit for general anesthetic
Key exclusion criteria (12 listed)
- <18 years old
- Unable to obtain informed consent from the patient or their medical representative.
- Medically unfit for general anesthesia
- Pregnant
- Necrotic collection not accessible by either or both techniques
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 treatmentAlso: Endoscopic cystogastrostomy, Endoscopic cystoduodenostomy, Endoscopic necrosectomyTreated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed. | Procedure or surgery | Endoscopic treatment |
| Minimally invasive surgical necrosectomyAlso: Video-assisted retroperitoneal debridement (VARD), Laparoscopic cystogastrostomy with internal debridementVideo-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement. | Procedure or surgery | Minimally invasive surgical necrosectomy |
Primary outcome
Major complications
Time frame: 6 months post discharge
Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge
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 11 Feb 2019.
- Derived from this study: PubMed 30452918Bang JY, Arnoletti JP, Holt BA, Sutton B, Hasan MK, Navaneethan U, Feranec N, Wilcox CM, Tharian B, Hawes RH, Varadarajulu S. An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis. Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031. Epub 2018 Nov 16.
- Individual participant dataSharing planned: No
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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.
Shyam S Varadarajulu, MD principal investigator
AdventHealth
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 treatment and Minimally invasive surgical necrosectomy in people with Necrosis of Pancreas and Infected Pancreatic Necrosis, run by AdventHealth at 1 site in United States.
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 7 inclusion and 12 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 11 Feb 2019. 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 United States. 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?
Major complications (time frame: 6 months post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084537, which also lists 1 linked publication.
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 11 Feb 2019.