Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

Официальное название

Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial

Обзор

The purpose of this study is to determine if the use of antiseptic-coated sutures is better than the use of the standard sutures in preventing postoperative fistulas within 90 days after pancreatoduodenectomy.

Подробное описание

This study is a randomized-controlled trial comparing the rate of post-operative pancreatic fistula (POPF) in patients undergoing pancreatoduodenectomy. This is a superiority study designed to determine whether the use of antiseptic-coated sutures (intervention arm) is superior to standard sutures (control arm) in regard to clinically significant POPF within 90 days following pancreatoduodenectomy. Patients will be randomized to receive either a pancreatoduodenectomy surgery utilizing antiseptic coated sutures or with non-coated standard sutures. The study hypothesize that the use of antiseptic-coated sutures will be associated with a reduction in the rate of POPF. Both sutures are currently available at our center and utilized in the procedure of interest.

Вмешательства

• Устройство Standard (non-antiseptic coated) suture will be used.
  This is an operation to treat tumors and other conditions in the pancreas, small intestine, and bile ducts. It involves removing the head of the pancreas, the first part of the small intestine, the gallbladder, and the bile duct. Part of the procedure involves sutures. A suture(s) is a stitch or row of stitches holding together the edges of a wound or surgical incision
• Устройство Triclosan/antiseptic -coated suture
  Triclosan/antiseptic -coated suture will be used. Ethicon PDSTM Plus Antibacterial Suture will be used at the layer of the pancreatojejunostomy and for the duration of the case.

Первичные конечные точки

• Comparison of the rate of postoperative pancreatic fistula [Срок оценки: up to 90 days post-operative]
• Comparison of the rate of postoperative pancreatic fistula [Срок оценки: up to 90 days post-operative]
• Comparison of the rate of postoperative pancreatic fistula [Срок оценки: up to 90-day post operative]

Вторичные конечные точки (8)

• Improvement in Rate of clinically significant POPF [Срок оценки: up to 90-days post-operative]
• Improvement in SSI rates between groups using CDC classification [Срок оценки: up to 90-days post-operative]
• Hospital Length of Stay [Срок оценки: up to 90-day post operative]
• Length of ICU stay [Срок оценки: up to 90-day post operative]
• Surgical Site Infection [Срок оценки: up to 90-day post operative]
• Surgical site occurrence [Срок оценки: Up to 90 days post-operative]
• Surgical Site Occurrence requiring Procedural Intervention [Срок оценки: up to 90 days post-operative]
• Post operative pancreatic fistula interventions [Срок оценки: Up to 90 days post-operative]

Критерии участия

Критерии включения

• Subjects must be undergoing a scheduled pancreatoduodenectomy.
• Age ≥18 years.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document

Критерии исключения

• Patients < 18 years old
• Patients who are pregnant
• Patients with history of previous pancreatic surgery
• Patients who are unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Cleveland Clinic Akron — Akron
• Cleveland Clinic — Cleveland
• Cleveland Clinic Fairview Hospital — Fairview

Публикации

• Shubert CR, Wagie AE, Farnell MB, Nagorney DM, Que FG, Reid Lombardo KM, Truty MJ, Smoot RL, Kendrick ML. Clinical Risk Score to Predict Pancreatic Fistula after Pancreatoduodenectomy: Independent External Validation for Open and Laparoscopic Approaches. J Am Coll Surg. 2015 Sep;221(3):689-98. doi: 10.1016/j.jamcollsurg.2015.05.011. Epub 2015 May 21. PMID 26296680
• Shubert CR, Kendrick ML, Habermann EB, Glasgow AE, Borah BJ, Moriarty JP, Cleary SP, Smoot RL, Farnell MB, Nagorney DM, Truty MJ, Que FG. Implementation of prospective, surgeon-driven, risk-based pathway for pancreatoduodenectomy results in improved clinical outcomes and first year cost savings of $1 million. Surgery. 2018 Mar;163(3):495-502. doi: 10.1016/j.surg.2017.10.022. Epub 2017 Dec 21. PMID 29275974
• Ocuin LM, Loftus A, Elshami M, Hue JJ, Musonza T, Ammori JB, Winter JM, Hardacre JM. Extended antibiotic therapy is associated with a lower rate of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy in intermediate- and high-risk patients: A single-institution analysis. Surgery. 2024 Feb;175(2):477-483. doi: 10.1016/j.surg.2023.09.049. Epub 2023 Nov 7. PMID 37940433
• Riall TS, Nealon WH, Goodwin JS, Townsend CM Jr, Freeman JL. Outcomes following pancreatic resection: variability among high-volume providers. Surgery. 2008 Aug;144(2):133-40. doi: 10.1016/j.surg.2008.03.041. PMID 18656618
• Krautz C, Nimptsch U, Weber GF, Mansky T, Grutzmann R. Effect of Hospital Volume on In-hospital Morbidity and Mortality Following Pancreatic Surgery in Germany. Ann Surg. 2018 Mar;267(3):411-417. doi: 10.1097/SLA.0000000000002248. PMID 28379871
• Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; Int PMID 28040257
• Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. doi: 10.3748/wjg.v11.i16.2456. PMID 15832417
• Sato N, Yamaguchi K, Chijiiwa K, Tanaka M. Risk analysis of pancreatic fistula after pancreatic head resection. Arch Surg. 1998 Oct;133(10):1094-8. doi: 10.1001/archsurg.133.10.1094. PMID 9790207

Идентификаторы

NCT: NCT07318493 · 24-575

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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