Pancreatitis, AcuteNCT06134024
The Role of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Pancreatic Fluid Collections.
A study testing Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections and Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only in people with Pancreatitis, Acute and Pancreatitis, Acute Necrotizing, run by Nicolaus Copernicus University.
Trial summary
The goal of this clinical trial is to learn about clinical usefulness of double pigtail plastic stents during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of lumen-apposing metal stents (LAMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst
- What is being tested?
- Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections and Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 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
- participants of both sexes aged above 18 years
- participants, who provided informed consent for such treatment
- eligibility for transmural endoscopic drainage of post-inflammatory pancreatic and peripancreatic fluid collections procedure according to current medical knowledge based on evidence-based medicine.
Who cannot join
- pregnancy, breastfeeding, or intention to become pregnant during the study
- contraindications to electrosurgical instruments
- allergy to any of the materials used in the study
- participants ineligible for endoscopic treatment
- participants ineligible for general anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Assessment of Effectiveness and Safety of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Post-inflammatory Pancreatic and Peripancreatic Fluid Collections With Use of Lumen-apposing Metal Stents (LAMS).
The goal of this clinical trial is to learn about clinical usefulness of double pigtail plastic stents during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of lumen-apposing metal stents (LAMS).
The main question it aims to answer is:
Does introduction of double pigtail plastic stents through the LAMS increases efficacy and safety of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections?
Read the detailed description
Acute pancreatitis (AP) of moderate-to-severe clinical course is associated with a high risk of local complications and organ failure leading to increased mortality. Pancreatic and peripancreatic fluid collections (PPFCs) that can appear in the late phase of pancreatitis can take the form of pancreatic pseudocysts and walled-off pancreatic necrosis (WOPN). These types of PPFCs are the most common local complications of acute and chronic pancreatitis. For many years, the traditional treatment of post-inflammatory PPFCs in the late phase of pancreatitis relied on surgical methods. However, there has been a recent dynamic development of minimally invasive techniques, including endoscopic transluminal methods. While endoscopic treatment is an established method of managing these complications, some aspects of endotherapy are still a source of much controversy. One of the most debated issues in interventional endoscopy of local complications in pancreatitis is the use of transmural self-expanding metallic stents (SEMSs).
Endoscopic transmural drainage consists of creating a fistula between the lumen of the PPFC and gastrointestinal tract to allow for a free outflow of fluid out of the PPFC and into the gastrointestinal tract. During an endoscopic ultrasound (EUS)-guided procedure of endoscopic transmural drainage of post-inflammatory PPFCs, this can be visualized in the endosonographic image through the wall of the upper gastrointestinal tract. Afterwards, a transmural puncture of the PPFC is performed under EUS guidance and widened with a cystotome to a diameter of 10 Fr using coagulation. This forms a transmural cystostomy, which joins the gastrointestinal tract and the lumen of the PPFC. The next step of the endoscopic procedure is mechanical (with a dilator) or pneumatic (with a high-pressure balloon) dilation of the pancreaticocystogastrostomy or pancreaticocystoduodenostomy. Once dilated, a transmural SEMS or plastic stent(s) is introduced through the cystostomy to facilitate free passive transmural drainage of the collection contents into the gastrointestinal tract. Passive transmural drainage is an effective method of endoscopic treatment of pancreatic pseudocysts, whose contents are entirely liquid. In the case of necrotic PPFCs that contain both liquefied necrotic material and tissue fragments, it is necessary to use active transmural drainage, which consists of inserting an additional nasal drain through the transmural cystostomy to enable flushing of the collection cavity in the postoperative period.
The development of advanced endoscopic techniques has led to rapid advancements in biomedical materials, including polymers for manufacturing endoscopic devices. Currently, there is a wide variety of transmural endoprostheses of different sizes, shapes, and designs for endoscopic treatment of post-inflammatory PPFCs. These endoprostheses were divided into two groups. The first group includes plastic stents, usually made of Teflon or polyethylene. The second group is SEMSs, often referred to as "lumen-apposing metal stents" (LAMSs), that are used in the treatment of post-inflammatory pancreatic local complications. For many years, the only type of endoprosthesis available for use in transmural drainage was plastic double-pigtail stents. However, LAMSs have been attracting increasing interest as a relatively new option in endoscopy. LAMSs are a special type of SEMS used in a variety of gastrointestinal endoscopic procedures. They are made of nitinol wire and are fully covered with a silicone membrane.
However, the role of LAMSs in transmural drainage remains unclear. Many authors believe that use of LAMS during endoscopic transmural drainage increases risk of complications in form of bleeding. Despite the development of advanced endoscopic techniques and devices, the high rates of bleeding into the PPFC lumen remain a major challenge in transmural drainage treatment. This type of complication is often caused by blood vessels adjacent to the fluid collection being damaged by the distal flange of the LAMS. It seems that inserting a plastic double-pigtail stent through the LAMS limits the risk of this kind of complication by moving the back wall of the PPFC away from the distal flange, PPFC cavity bleeding during transmural drainage is still a major complication associated with a high risk of fatal outcomes.
In this trial the participants with post-inflammatory PPFCs will be divided into two arms.
The first arm will consist of participants who underwent traditional transmural drainage procedure with use of LAMS only.
The second arm will consist of participants with PPFCs who underwent endoscopic transmural drainage with use of LAMS and during the procedure double pigtail plastic stents will be introduced through the LAMS in order to prevent bleeding.
Each arm will consist of at least 50 participants with post-inflammatory PPFCs.
- Conditions
- Pancreatitis, Acute, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst, Pancreatic Necrosis, Pancreatitis, Chronic
- Being tested
- Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections, Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only
- Keywords
- gastrointestinal endoscopy, transmural drainage, lams, double pigtail plastic stents, endoscopic drainage
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collectionsProcedure or surgery
During endoscopic procedure of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections the operator introduces double pigtail plastic stents through the LAMS.
Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS onlyProcedure or surgery
During endoscopic procedure of transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections the operator introduces transmurally the LAMS only, without the double pigtail plastic stents.
| Study group | Role | What they receive |
|---|---|---|
| LAMS with Double Pigtail Plastic Stents | Experimental | The group of participants with post-inflammatory pancreatic and peripancreatic fluid collections with double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage. Receives: Procedure: Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections |
| LAMS without Double Pigtail Plastic Stents | Active comparator | The group of participants with post-inflammatory pancreatic and peripancreatic fluid collections without double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage. Receives: Procedure: Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of efficacy of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Evaluation of efficacy based on clinical picture and results of imaging examinations.
Measured: 12 months
Rate of safety of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Evaluation of safety based on clinical picture and results of imaging examinations.
Measured: 12 months
Secondary outcomes (4)
Rate of early complications during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Evaluation of early complications within thirty days from onset of endoscopic drainage.
Measured: 30 days
Rate of late complications during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Evaluation of late complications of endoscopic drainage.
Measured: 12 months
Rate of clinical success of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Assessment of clinical results of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Measured: 3 months
Rate of long-term success of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Assessment of long-term results of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
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 posted18 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Jagielski, Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134024
- Sponsor's protocol ID
- DGGOS/MJ/2/2023
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thoeni RF. The revised Atlanta classification of acute pancreatitis: its importance for the radiologist and its effect on treatment. Radiology. 2012 Mar;262(3):751-64. doi: 10.1148/radiol.11110947.
PubMed 22357880Sarr MG. 2012 revision of the Atlanta classification of acute pancreatitis. Pol Arch Med Wewn. 2013;123(3):118-24. doi: 10.20452/pamw.1627. Epub 2013 Jan 25.
PubMed 23396317Manrai M, Kochhar R, Gupta V, Yadav TD, Dhaka N, Kalra N, Sinha SK, Khandelwal N. Outcome of Acute Pancreatic and Peripancreatic Collections Occurring in Patients With Acute Pancreatitis. Ann Surg. 2018 Feb;267(2):357-363. doi: 10.1097/SLA.0000000000002065.
PubMed 27805963Freeman ML, Werner J, van Santvoort HC, Baron TH, Besselink MG, Windsor JA, Horvath KD, vanSonnenberg E, Bollen TL, Vege SS; International Multidisciplinary Panel of Speakers and Moderators. Interventions for necrotizing pancreatitis: summary of a multidisciplinary consensus conference. Pancreas. 2012 Nov;41(8):1176-94. doi: 10.1097/MPA.0b013e318269c660.
PubMed 23086243Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9.
PubMed 29631305Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31.
PubMed 31479658da Costa DW, Boerma D, van Santvoort HC, Horvath KD, Werner J, Carter CR, Bollen TL, Gooszen HG, Besselink MG, Bakker OJ. Staged multidisciplinary step-up management for necrotizing pancreatitis. Br J Surg. 2014 Jan;101(1):e65-79. doi: 10.1002/bjs.9346. Epub 2013 Nov 22.
PubMed 24272964Szeliga J, Jackowski M. Minimally invasive procedures in severe acute pancreatitis treatment - assessment of benefits and possibilities of use. Wideochir Inne Tech Maloinwazyjne. 2014 Jun;9(2):170-8. doi: 10.5114/wiitm.2014.41628. Epub 2014 Apr 1.
PubMed 25097683Bazerbachi F, Sawas T, Vargas EJ, Prokop LJ, Chari ST, Gleeson FC, Levy MJ, Martin J, Petersen BT, Pearson RK, Topazian MD, Vege SS, Abu Dayyeh BK. Metal stents versus plastic stents for the management of pancreatic walled-off necrosis: a systematic review and meta-analysis. Gastrointest Endosc. 2018 Jan;87(1):30-42.e15. doi: 10.1016/j.gie.2017.08.025. Epub 2017 Sep 1.
PubMed 28867073Beran A, Mohamed MFH, Abdelfattah T, Sarkis Y, Montrose J, Sayeh W, Musallam R, Jaber F, Elfert K, Montalvan-Sanchez E, Al-Haddad M. Lumen-Apposing Metal Stent With and Without Concurrent Double-Pigtail Plastic Stent for Pancreatic Fluid Collections: A Comparative Systematic Review and Meta-Analysis. Gastroenterology Res. 2023 Apr;16(2):59-67. doi: 10.14740/gr1601. Epub 2023 Apr 28.
PubMed 37187554Saumoy M, Kahaleh M. Superiority of metal stents for pancreatic walled-off necrosis: bigger is better! Gastrointest Endosc. 2017 Jun;85(6):1253-1254. doi: 10.1016/j.gie.2017.03.008. No abstract available.
PubMed 28522015Jagielski M, Smoczynski M, Szeliga J, Adrych K, Jackowski M. Various Endoscopic Techniques for Treatment of Consequences of Acute Necrotizing Pancreatitis: Practical Updates for the Endoscopist. J Clin Med. 2020 Jan 1;9(1):117. doi: 10.3390/jcm9010117.
PubMed 31906294
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Effectiveness and Safety of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Post-inflammatory Pancreatic and Peripancreatic Fluid Collections With Use of Lumen-apposing Metal Stents (LAMS).
- ClinicalTrials.gov ID
- NCT06134024
- Acronym / sponsor ID
- DGGOS/MJ/2/2023
- Conditions
- Pancreatitis, Acute, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst, Pancreatic Necrosis, Pancreatitis, Chronic
- Keywords
- gastrointestinal endoscopy, transmural drainage, lams, double pigtail plastic stents, endoscopic drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
The goal of this clinical trial is to learn about clinical usefulness of double pigtail plastic stents during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of lumen-apposing metal stents (LAMS).
The main question it aims to answer is:
Does introduction of double pigtail plastic stents through the LAMS increases efficacy and safety of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections?
Detailed description
Acute pancreatitis (AP) of moderate-to-severe clinical course is associated with a high risk of local complications and organ failure leading to increased mortality. Pancreatic and peripancreatic fluid collections (PPFCs) that can appear in the late phase of pancreatitis can take the form of pancreatic pseudocysts and walled-off pancreatic necrosis (WOPN). These types of PPFCs are the most common local complications of acute and chronic pancreatitis. For many years, the traditional treatment of post-inflammatory PPFCs in the late phase of pancreatitis relied on surgical methods. However, there has been a recent dynamic development of minimally invasive techniques, including endoscopic transluminal methods. While endoscopic treatment is an established method of managing these complications, some aspects of endotherapy are still a source of much controversy. One of the most debated issues in interventional endoscopy of local complications in pancreatitis is the use of transmural self-expanding metallic stents (SEMSs).
Endoscopic transmural drainage consists of creating a fistula between the lumen of the PPFC and gastrointestinal tract to allow for a free outflow of fluid out of the PPFC and into the gastrointestinal tract. During an endoscopic ultrasound (EUS)-guided procedure of endoscopic transmural drainage of post-inflammatory PPFCs, this can be visualized in the endosonographic image through the wall of the upper gastrointestinal tract. Afterwards, a transmural puncture of the PPFC is performed under EUS guidance and widened with a cystotome to a diameter of 10 Fr using coagulation. This forms a transmural cystostomy, which joins the gastrointestinal tract and the lumen of the PPFC. The next step of the endoscopic procedure is mechanical (with a dilator) or pneumatic (with a high-pressure balloon) dilation of the pancreaticocystogastrostomy or pancreaticocystoduodenostomy. Once dilated, a transmural SEMS or plastic stent(s) is introduced through the cystostomy to facilitate free passive transmural drainage of the collection contents into the gastrointestinal tract. Passive transmural drainage is an effective method of endoscopic treatment of pancreatic pseudocysts, whose contents are entirely liquid. In the case of necrotic PPFCs that contain both liquefied necrotic material and tissue fragments, it is necessary to use active transmural drainage, which consists of inserting an additional nasal drain through the transmural cystostomy to enable flushing of the collection cavity in the postoperative period.
The development of advanced endoscopic techniques has led to rapid advancements in biomedical materials, including polymers for manufacturing endoscopic devices. Currently, there is a wide variety of transmural endoprostheses of different sizes, shapes, and designs for endoscopic treatment of post-inflammatory PPFCs. These endoprostheses were divided into two groups. The first group includes plastic stents, usually made of Teflon or polyethylene. The second group is SEMSs, often referred to as "lumen-apposing metal stents" (LAMSs), that are used in the treatment of post-inflammatory pancreatic local complications. For many years, the only type of endoprosthesis available for use in transmural drainage was plastic double-pigtail stents. However, LAMSs have been attracting increasing interest as a relatively new option in endoscopy. LAMSs are a special type of SEMS used in a variety of gastrointestinal endoscopic procedures. They are made of nitinol wire and are fully covered with a silicone membrane.
However, the role of LAMSs in transmural drainage remains unclear. Many authors believe that use of LAMS during endoscopic transmural drainage increases risk of complications in form of bleeding. Despite the development of advanced endoscopic techniques and devices, the high rates of bleeding into the PPFC lumen remain a major challenge in transmural drainage treatment. This type of complication is often caused by blood vessels adjacent to the fluid collection being damaged by the distal flange of the LAMS. It seems that inserting a plastic double-pigtail stent through the LAMS limits the risk of this kind of complication by moving the back wall of the PPFC away from the distal flange, PPFC cavity bleeding during transmural drainage is still a major complication associated with a high risk of fatal outcomes.
In this trial the participants with post-inflammatory PPFCs will be divided into two arms.
The first arm will consist of participants who underwent traditional transmural drainage procedure with use of LAMS only.
The second arm will consist of participants with PPFCs who underwent endoscopic transmural drainage with use of LAMS and during the procedure double pigtail plastic stents will be introduced through the LAMS in order to prevent bleeding.
Each arm will consist of at least 50 participants with post-inflammatory PPFCs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAMS with Double Pigtail Plastic Stents | Experimental | Procedure: Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collectionsThe group of participants with post-inflammatory pancreatic and peripancreatic fluid collections with double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage. |
| LAMS without Double Pigtail Plastic Stents | Active comparator | Procedure: Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS onlyThe group of participants with post-inflammatory pancreatic and peripancreatic fluid collections without double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants of both sexes aged above 18 years
- participants, who provided informed consent for such treatment
- eligibility for transmural endoscopic drainage of post-inflammatory pancreatic and peripancreatic fluid collections procedure according to current medical knowledge based on evidence-based medicine.
Key exclusion criteria (5 listed)
- pregnancy, breastfeeding, or intention to become pregnant during the study
- contraindications to electrosurgical instruments
- allergy to any of the materials used in the study
- participants ineligible for endoscopic treatment
- participants ineligible for general anesthesia
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 |
|---|---|---|
| Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collectionsDuring endoscopic procedure of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections the operator introduces double pigtail plastic stents through the LAMS. | Procedure or surgery | LAMS with Double Pigtail Plastic Stents |
| Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS onlyDuring endoscopic procedure of transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections the operator introduces transmurally the LAMS only, without the double pigtail plastic stents. | Procedure or surgery | LAMS without Double Pigtail Plastic Stents |
Primary outcome
Rate of efficacy of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Time frame: 12 months
Evaluation of efficacy based on clinical picture and results of imaging examinations.
Rate of safety of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Time frame: 12 months
Evaluation of safety based on clinical picture and results of imaging examinations.
4 secondary outcomes
Rate of early complications during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Time frame: 30 days
Rate of late complications during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Time frame: 12 months
Rate of clinical success of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Time frame: 3 months
Rate of long-term success of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 22357880Thoeni RF. The revised Atlanta classification of acute pancreatitis: its importance for the radiologist and its effect on treatment. Radiology. 2012 Mar;262(3):751-64. doi: 10.1148/radiol.11110947.
- Background: PubMed 23396317Sarr MG. 2012 revision of the Atlanta classification of acute pancreatitis. Pol Arch Med Wewn. 2013;123(3):118-24. doi: 10.20452/pamw.1627. Epub 2013 Jan 25.
- Background: PubMed 27805963Manrai M, Kochhar R, Gupta V, Yadav TD, Dhaka N, Kalra N, Sinha SK, Khandelwal N. Outcome of Acute Pancreatic and Peripancreatic Collections Occurring in Patients With Acute Pancreatitis. Ann Surg. 2018 Feb;267(2):357-363. doi: 10.1097/SLA.0000000000002065.
- Background: PubMed 23086243Freeman ML, Werner J, van Santvoort HC, Baron TH, Besselink MG, Windsor JA, Horvath KD, vanSonnenberg E, Bollen TL, Vege SS; International Multidisciplinary Panel of Speakers and Moderators. Interventions for necrotizing pancreatitis: summary of a multidisciplinary consensus conference. Pancreas. 2012 Nov;41(8):1176-94. doi: 10.1097/MPA.0b013e318269c660.
- Background: PubMed 29631305Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9.
- Background: PubMed 31479658Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31.
- Background: PubMed 24272964da Costa DW, Boerma D, van Santvoort HC, Horvath KD, Werner J, Carter CR, Bollen TL, Gooszen HG, Besselink MG, Bakker OJ. Staged multidisciplinary step-up management for necrotizing pancreatitis. Br J Surg. 2014 Jan;101(1):e65-79. doi: 10.1002/bjs.9346. Epub 2013 Nov 22.
- Background: PubMed 25097683Szeliga J, Jackowski M. Minimally invasive procedures in severe acute pancreatitis treatment - assessment of benefits and possibilities of use. Wideochir Inne Tech Maloinwazyjne. 2014 Jun;9(2):170-8. doi: 10.5114/wiitm.2014.41628. Epub 2014 Apr 1.
- Background: PubMed 28867073Bazerbachi F, Sawas T, Vargas EJ, Prokop LJ, Chari ST, Gleeson FC, Levy MJ, Martin J, Petersen BT, Pearson RK, Topazian MD, Vege SS, Abu Dayyeh BK. Metal stents versus plastic stents for the management of pancreatic walled-off necrosis: a systematic review and meta-analysis. Gastrointest Endosc. 2018 Jan;87(1):30-42.e15. doi: 10.1016/j.gie.2017.08.025. Epub 2017 Sep 1.
- Background: PubMed 37187554Beran A, Mohamed MFH, Abdelfattah T, Sarkis Y, Montrose J, Sayeh W, Musallam R, Jaber F, Elfert K, Montalvan-Sanchez E, Al-Haddad M. Lumen-Apposing Metal Stent With and Without Concurrent Double-Pigtail Plastic Stent for Pancreatic Fluid Collections: A Comparative Systematic Review and Meta-Analysis. Gastroenterology Res. 2023 Apr;16(2):59-67. doi: 10.14740/gr1601. Epub 2023 Apr 28.
- Background: PubMed 28522015Saumoy M, Kahaleh M. Superiority of metal stents for pancreatic walled-off necrosis: bigger is better! Gastrointest Endosc. 2017 Jun;85(6):1253-1254. doi: 10.1016/j.gie.2017.03.008. No abstract available.
- Background: PubMed 31906294Jagielski M, Smoczynski M, Szeliga J, Adrych K, Jackowski M. Various Endoscopic Techniques for Treatment of Consequences of Acute Necrotizing Pancreatitis: Practical Updates for the Endoscopist. J Clin Med. 2020 Jan 1;9(1):117. doi: 10.3390/jcm9010117.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections and Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only in people with Pancreatitis, Acute and Pancreatitis, Acute Necrotizing, run by Nicolaus Copernicus University.
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 5 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mateusz Jagielski, Prof. (+48566793199 ext. +48, matjagiel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of efficacy of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT06134024, which also lists 12 linked publications.
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 18 Nov 2023.