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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Wakayama
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811-1 Kimiidera, Wakayama, Wakayama, Japan, 641-8510
- Rekruttering
- Wakayama Medical University , Second Department of Surgery
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Ta kontakt med:
- Hiroki Yamaue, MD
- Telefonnummer: +81-73-441-0612
- E-post: yamaue-h@wakayama-med.ac.jp
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Ta kontakt med:
- Masaji Tani, MD
- Telefonnummer: +81-73-441-0613
- E-post: matani@wakayama-med.ac.jp
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Hovedetterforsker:
- Masaji Tani, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Billroth-II-type
Billroth-II-type reconstruction after pancreaticoduodenectomy
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surgical procedure
Andre navn:
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Eksperimentell: Isolated Roux-en-Y
Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
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surgical procedure
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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the incidence of pancreatic fistula
Tidsramme: 3 months after operation
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3 months after operation
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess
Tidsramme: 3 months after operation
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3 months after operation
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Masaji Tani, MD, Wakayama Medical University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter nettsted
- Sykdommer i det endokrine systemet
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i endokrine kjertel
- Tarmsykdommer
- Intestinale neoplasmer
- Duodenale sykdommer
- Galleveissykdommer
- Pankreassykdommer
- Galleveissykdommer
- Neoplasmer i galleveiene
- Neoplasmer
- Neoplasmer i bukspyttkjertelen
- Pankreatitt
- Gallekanalsneoplasmer
- Duodenale neoplasmer
Andre studie-ID-numre
- WP-0901
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