Acute Pancreatitis NecrotizingNCT03436043
Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct
A study testing Transmural Plastic stenting in people with Acute Pancreatitis Necrotizing, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Walled of necrosis (WON) is severe local complication of acute necrotizing pancreatitis. Disconnected pancreatic duct syndrome(DPDS) is commonly seen (50-60%) after necrotizing pancreatitis and has long term implication like recurrent pancreatic fluid collections (PFC)] requiring re-intervention. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pancreatitis Necrotizing
- What is being tested?
- Transmural Plastic stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 20 Oct 2017to 5 Nov 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patient who underwent EUS guided drainage with metal stent DPDS on MRCP \& ERCP
Who cannot join
- Unwillingness to give written informed consent MRCP/ERCP-PD stricture ? (mimics DPD), leak Bleeding diathesis (Coagulopathy \& thrombocytopenia) chronic pancreatitis
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, 500082
About this study
Official title: Does Transmural Plastic Stenting Prevent the Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Walled Off Necrosis With Disconnected Pancreatic Duct Syndrome ? -Prospective Randomized Controlled Trial
Walled of necrosis (WON) is severe local complication of acute necrotizing pancreatitis. Disconnected pancreatic duct syndrome(DPDS) is commonly seen (50-60%) after necrotizing pancreatitis and has long term implication like recurrent pancreatic fluid collections (PFC)] requiring re-intervention. Incidence of recurrent PFC is more common in patients with DPDS (17-50%) compared to others. Studies has shown permanent in-dwelling transmural stent reduces recurrence of PFC (1.7% vs 17.4%, p<0.001). Nowadays,WON is effectively managed with endoscopic step up approach (96%). Several studies showed dedicated self-expandable metal stent (SEMS) are effective compared to the plastic stents in management of WON with decreased need of re-intervention. However, SEMS cannot be kept for longer duration because of associated adverse events. So, experts recommend to remove SEMS within 4-6 weeks of placement. Considering this background, study is planned with aim to see the effect of transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis with DPDS.
Read the detailed description
Acute necrotizing pancreatitis (ANP) is lethal complication and account for 10-20% of total pancreatitis. Necrotic collection is seen in majority of ANP and >50% of necrotic collection transform into Walled of necrosis (WON). Management of WON is challenging and under progressive evolution. With the advent of "step up approach" WON is effectively managed with greater success. Various studies and meta-analysis proved the efficacy of dedicated self-expandable metal stents (SEMS) over plastic stent in WON management. Disconnected pancreatic duct syndrome (DPDS) is late complication of necrotizing pancreatitis and increasingly identified after necrosectomy. DPDS is defined as complete disruption of the main pancreatic duct, resulting in a variable portion of the upstream pancreatic gland becoming isolated from the main pancreatic duct downstream. Ductal disruption leads to accumulation of pancreatic juice forming pancreatic or peri-pancreatic fluid collection. Incidence of recurrence of PFC in DPD is ~ 50%. DPDS is a separate clinical entity which demands special strategic approach and requires frequent re-intervention (surgical/endoscopic). Treatment option for DPDS is controversial and not yet clearly defined. Studies have shown that long term transmural plastic stent placement can reduce the recurrence rate (Stent removed-17% vs stent left behind-1.7%). So, some experts recommend that transmural stents can be left in situ indefinitely to decrease recurrence of PFC. Nowadays, SEMS are widely used for management of WON. However, metal stents cannot be kept for longer period because of increasing adverse events associated with longer duration (impaction/burring of SEMS in gastric wall, bleeding). So, recommendation is to remove SEMS as early as possible (within 4-6 weeks of drainage). Considering this fact, study is planned to evaluate the effect of transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis with DPDS. This will be randomised control study in patients with WON with DPDS who underwent SEMS drainage. After removal of SEMS patients with documented DPDS (magnetic resonance pancreatography and endoscopic retrograde pancreatography) will be randomised into 2 arms. In study arm after SEMS removal transmural plastic stent will be placed in to the cavity and in control arm SEMS will be removed with no transmural stenting. Thereafter patients will be followed at 3 months,6 months and yearly.
- Conditions
- Acute Pancreatitis Necrotizing
- Being tested
- Transmural Plastic stenting
- Keywords
- Walled of necrosis
- 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.
Transmural Plastic stentingDevice
After metal stent removal in patients of disconnected pancreatic duct syndrome, transmural plastic- double pig tail stent will be placed into the residual necrotic cavity with the standard duodenoscope.
| Study group | Role | What they receive |
|---|---|---|
| Transmural stenting | Experimental | In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks followed by transmural plastic stenting in the residual cavity. Receives: Device: Transmural Plastic stenting |
| No stenting | No intervention | In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks without any further intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of PFC
In the study will see the re-ccurence of fluid collection in control and study arm
Measured: 3 months
Secondary outcomes (1)
Technical Success
complication associated with deployment of transmural plastic, stent migration,recurrence of pancreatic fluid collection at 6 months and 1 year,new onset diabetes mellitus
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start20 Oct 2017
- Primary completion27 Mar 2020
- Study completion5 Nov 2020
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 Acute Pancreatitis NecrotizingStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436043
- Sponsor's protocol ID
- AIG-006
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chavan R, Nabi Z, Lakhtakia S, Gupta R, Jahangeer B, Talukdar R, Singh AP, Karyampudi A, Yarlagadda R, Ramchandani M, Kalapala R, Jagtap N, Reddy M, Tandan M, Rao GV, Reddy ND. Impact of transmural plastic stent on recurrence of pancreatic fluid collection after metal stent removal in disconnected pancreatic duct: a randomized controlled trial. Endoscopy. 2022 Sep;54(9):861-868. doi: 10.1055/a-1747-3283. Epub 2022 Feb 18.
PubMed 35180798
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transmural Plastic Stenting Prevent the Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Walled Off Necrosis With Disconnected Pancreatic Duct Syndrome ? -Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03436043
- Acronym / sponsor ID
- AIG-006
- Conditions
- Acute Pancreatitis Necrotizing
- Keywords
- Walled of necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 19 Feb 2018 (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 of necrosis (WON) is severe local complication of acute necrotizing pancreatitis. Disconnected pancreatic duct syndrome(DPDS) is commonly seen (50-60%) after necrotizing pancreatitis and has long term implication like recurrent pancreatic fluid collections (PFC)] requiring re-intervention. Incidence of recurrent PFC is more common in patients with DPDS (17-50%) compared to others. Studies has shown permanent in-dwelling transmural stent reduces recurrence of PFC (1.7% vs 17.4%, p<0.001). Nowadays,WON is effectively managed with endoscopic step up approach (96%). Several studies showed dedicated self-expandable metal stent (SEMS) are effective compared to the plastic stents in management of WON with decreased need of re-intervention. However, SEMS cannot be kept for longer duration because of associated adverse events. So, experts recommend to remove SEMS within 4-6 weeks of placement. Considering this background, study is planned with aim to see the effect of transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis with DPDS.
Detailed description
Acute necrotizing pancreatitis (ANP) is lethal complication and account for 10-20% of total pancreatitis. Necrotic collection is seen in majority of ANP and >50% of necrotic collection transform into Walled of necrosis (WON). Management of WON is challenging and under progressive evolution. With the advent of "step up approach" WON is effectively managed with greater success. Various studies and meta-analysis proved the efficacy of dedicated self-expandable metal stents (SEMS) over plastic stent in WON management. Disconnected pancreatic duct syndrome (DPDS) is late complication of necrotizing pancreatitis and increasingly identified after necrosectomy. DPDS is defined as complete disruption of the main pancreatic duct, resulting in a variable portion of the upstream pancreatic gland becoming isolated from the main pancreatic duct downstream. Ductal disruption leads to accumulation of pancreatic juice forming pancreatic or peri-pancreatic fluid collection. Incidence of recurrence of PFC in DPD is ~ 50%. DPDS is a separate clinical entity which demands special strategic approach and requires frequent re-intervention (surgical/endoscopic). Treatment option for DPDS is controversial and not yet clearly defined. Studies have shown that long term transmural plastic stent placement can reduce the recurrence rate (Stent removed-17% vs stent left behind-1.7%). So, some experts recommend that transmural stents can be left in situ indefinitely to decrease recurrence of PFC. Nowadays, SEMS are widely used for management of WON. However, metal stents cannot be kept for longer period because of increasing adverse events associated with longer duration (impaction/burring of SEMS in gastric wall, bleeding). So, recommendation is to remove SEMS as early as possible (within 4-6 weeks of drainage). Considering this fact, study is planned to evaluate the effect of transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis with DPDS. This will be randomised control study in patients with WON with DPDS who underwent SEMS drainage. After removal of SEMS patients with documented DPDS (magnetic resonance pancreatography and endoscopic retrograde pancreatography) will be randomised into 2 arms. In study arm after SEMS removal transmural plastic stent will be placed in to the cavity and in control arm SEMS will be removed with no transmural stenting. Thereafter patients will be followed at 3 months,6 months and yearly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmural stenting | Experimental | Device: Transmural Plastic stentingIn patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks followed by transmural plastic stenting in the residual cavity. |
| No stenting | No intervention | –In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks without any further intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All the patient who underwent EUS guided drainage with metal stent DPDS on MRCP \& ERCP
Key exclusion criteria (1 listed)
- Unwillingness to give written informed consent MRCP/ERCP-PD stricture ? (mimics DPD), leak Bleeding diathesis (Coagulopathy \& thrombocytopenia) chronic pancreatitis
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 |
|---|---|---|
| Transmural Plastic stentingAfter metal stent removal in patients of disconnected pancreatic duct syndrome, transmural plastic- double pig tail stent will be placed into the residual necrotic cavity with the standard duodenoscope. | Device | Transmural stenting |
Primary outcome
Recurrence of PFC
Time frame: 3 months
In the study will see the re-ccurence of fluid collection in control and study arm
1 secondary outcome
Technical Success
Time frame: 24 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 30 Jun 2021.
- Derived from this study: PubMed 35180798Chavan R, Nabi Z, Lakhtakia S, Gupta R, Jahangeer B, Talukdar R, Singh AP, Karyampudi A, Yarlagadda R, Ramchandani M, Kalapala R, Jagtap N, Reddy M, Tandan M, Rao GV, Reddy ND. Impact of transmural plastic stent on recurrence of pancreatic fluid collection after metal stent removal in disconnected pancreatic duct: a randomized controlled trial. Endoscopy. 2022 Sep;54(9):861-868. doi: 10.1055/a-1747-3283. Epub 2022 Feb 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transmural Plastic stenting in people with Acute Pancreatitis Necrotizing, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 1 inclusion and 1 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 30 Jun 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 India. 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?
Recurrence of PFC (time frame: 3 months). 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 NCT03436043, 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 30 Jun 2021.