Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this study is to clarify whether isolated Roux-en-Y reconstruction declines the incidence of postoperative complications after pancreaticoduodenectomy compared with Billroth-II-type reconstruction. Especially, it is important to decline the incidence of pancreatic fistula, because pancreatic fistula affects a postoperative course. However, there is no report that demonstrated postoperative complications of isolated Roux-en-Y compared with those of Billroth-II-type reconstruction. We conducted a prospective randomized trial on patients who underwent pancreaticoduodenectomy.
Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital.
The primary endpoint was defined as the incidence of pancreatic fistula. The secondary endpoints were the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital (WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Wakayama
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811-1 Kimiidera, Wakayama, Wakayama, Japan, 641-8510
- Werving
- Wakayama Medical University , Second Department of Surgery
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Contact:
- Hiroki Yamaue, MD
- Telefoonnummer: +81-73-441-0612
- E-mail: yamaue-h@wakayama-med.ac.jp
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Contact:
- Masaji Tani, MD
- Telefoonnummer: +81-73-441-0613
- E-mail: matani@wakayama-med.ac.jp
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Hoofdonderzoeker:
- Masaji Tani, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- the patients had undergone pancreatic head resection at Wakayama Medical University the patients obtained appropriate informed consent
Exclusion Criteria:
- young patients (less than 20-years-old)
- patients with severe complications which were possible to prolong hospital stay
- patients undergone hemodialysis
- patients combined resection of other organs
- patients who were diagnosed inadequacy for this study by a physician
- patients without an informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Billroth-II-type
Billroth-II-type reconstruction after pancreaticoduodenectomy
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surgical procedure
Andere namen:
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Experimenteel: Isolated Roux-en-Y
Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
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surgical procedure
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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the incidence of pancreatic fistula
Tijdsspanne: 3 months after operation
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3 months after operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess
Tijdsspanne: 3 months after operation
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3 months after operation
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Masaji Tani, MD, Wakayama Medical University
Publicaties en nuttige links
Algemene publicaties
- Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.
- Tani M, Kawai M, Terasawa H, Ina S, Hirono S, Uchiyama K, Yamaue H. Does postoperative chemotherapy have a survival benefit for patients with pancreatic cancer? J Surg Oncol. 2006 May 1;93(6):485-90. doi: 10.1002/jso.20440.
- Tani M, Terasawa H, Kawai M, Ina S, Hirono S, Uchiyama K, Yamaue H. Improvement of delayed gastric emptying in pylorus-preserving pancreaticoduodenectomy: results of a prospective, randomized, controlled trial. Ann Surg. 2006 Mar;243(3):316-20. doi: 10.1097/01.sla.0000201479.84934.ca.
- Tani M, Onishi H, Kinoshita H, Kawai M, Ueno M, Hama T, Uchiyama K, Yamaue H. The evaluation of duct-to-mucosal pancreaticojejunostomy in pancreaticoduodenectomy. World J Surg. 2005 Jan;29(1):76-9. doi: 10.1007/s00268-004-7507-0.
- Tani M, Kawai M, Terasawa H, Ueno M, Hama T, Hirono S, Ina S, Uchiyama K, Yamaue H. Complications with reconstruction procedures in pylorus-preserving pancreaticoduodenectomy. World J Surg. 2005 Jul;29(7):881-4. doi: 10.1007/s00268-005-7697-0.
- Busquets J, Martin S, Fabregat J, Secanella L, Pelaez N, Ramos E. Randomized trial of two types of gastrojejunostomy after pancreatoduodenectomy and risk of delayed gastric emptying (PAUDA trial). Br J Surg. 2019 Jan;106(1):46-54. doi: 10.1002/bjs.11023. Epub 2018 Dec 3.
- Tani M, Kawai M, Hirono S, Okada KI, Miyazawa M, Shimizu A, Kitahata Y, Yamaue H. Randomized clinical trial of isolated Roux-en-Y versus conventional reconstruction after pancreaticoduodenectomy. Br J Surg. 2014 Aug;101(9):1084-91. doi: 10.1002/bjs.9544. Epub 2014 Jun 26.
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata per site
- Endocriene systeemziekten
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Endocriene klierneoplasmata
- Darmziekten
- Intestinale neoplasmata
- Ziekten van de twaalfvingerige darm
- Ziekten van de galwegen
- Alvleesklier Ziekten
- Galwegaandoeningen
- Neoplasmata van de galwegen
- Neoplasmata
- Pancreasneoplasmata
- Pancreatitis
- Galwegneoplasmata
- Neoplasmata van de twaalfvingerige darm
Andere studie-ID-nummers
- WP-0901
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