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

NCT06134024 | Unknown

• 1 other identifier: DGGOS/MJ/2/2023
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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?

Conditions

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

Keywords

gastrointestinal endoscopy; transmural drainage; lams; double pigtail plastic stents; endoscopic drainage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 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.

  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.

  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.

  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.

  24 months

Study Arms (2)

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.

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.

Procedure: Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only

Interventions

Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections PROCEDURE

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.

LAMS with Double Pigtail Plastic Stents

Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only PROCEDURE

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.

LAMS without Double Pigtail Plastic Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

Related Publications (12)

• 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.

  PMID: 22357880 BACKGROUND

• 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.

  PMID: 23396317 BACKGROUND

• 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.

  PMID: 27805963 BACKGROUND

• 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.

  PMID: 23086243 BACKGROUND

• 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.

  PMID: 29631305 BACKGROUND

• 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.

  PMID: 31479658 BACKGROUND

• 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.

  PMID: 24272964 BACKGROUND

• 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.

  PMID: 25097683 BACKGROUND

• 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.

  PMID: 28867073 BACKGROUND

• 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.

  PMID: 37187554 BACKGROUND

• 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.

  PMID: 28522015 BACKGROUND

• 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.

  PMID: 31906294 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing; Pancreatic Pseudocyst; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pancreatic Cyst; Cysts; Neoplasms; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mateusz Jagielski, Prof.

CONTACT

+48566793199; matjagiel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share