The Role of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Pancreatic Fluid Collections.

Pancreatitis, Chronic Clinical Trial

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06134024
• Other study ID #: DGGOS/MJ/2/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Nicolaus Copernicus University
• Contact: Mateusz Jagielski, Prof.
• Phone: +48566793199
• Email: matjagiel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Necrosis
• Pancreatic Necrosis
• Pancreatic Pseudocyst
• Pancreatitis
• Pancreatitis, Acute
• Pancreatitis, Acute Necrotizing
• Pancreatitis, Chronic

Intervention

Procedure:
• Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections
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 only
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaus Copernicus University

References & Publications (12)

Arvanitakis 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. — View Citation

Baron 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. — View Citation

Bazerbachi 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. — View Citation

Beran 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. — View Citation

da 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. — View Citation

Freeman 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. — View Citation

Jagielski 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. — View Citation

Manrai 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. — View Citation

Sarr 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. — View Citation

Saumoy 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. Erratum In: Gastrointest Endosc. 2017 Jul;86(1):252. — View Citation

Szeliga 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. — View Citation

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* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months
Secondary	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.	30 days
Secondary	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.	12 months
Secondary	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.	3 months
Secondary	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.	24 months