Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy (PD)
Pancreaticoduodenectomy (PD)is the treatment of choice for patients with periampullary tumour (benign or malignant). In the recent years, the mortality rate of PD has decreased to 5% in many centers. However, pancreatic fistula (POPF) still occurs in 5 % to 40% of patients after PD. The hypothesis that isolated Roux loop PJ with isolated pancreatic drainage decrease the incidence of PF and severity with preservation of pancreatic function.
So the investigators compare isolated Roux Loop Pancreaticojejunostomy (PJ) Versus Pancreaticogastrostomy (PG) as regards incidence of POPF, severity of POPF and functional outcome.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The hypothesis that isolated Roux loop PJ decrease the incidence of PF and severity with preservation of pancreatic function (exocrine and endocrine functions).
Preoperative evaluation included abdominal CT, liver function, tumor marker CEA, CA19-9, preoperative ERCP were optional in selected cases (patients with high bilirubin with high enzymes. Patients with distant metastasis or locally advanced were excluded.
Informed consent was obtained from all patients entered in the study Randomization: enrolled patients were randomized intraoperatively after PD resection to either isolated Roux PJ with isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the nurse.
Operative technique. Standard PD with regional lymphadenectomy was performed. PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa.
Isolated Roux PJ group, reconstruction was begun using the transected jejunum and, which was anastomosed in end to side fashion. A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ). The PJ loop was anastomosed to the main loop (20 cm caudal to GJ).
One intrabdominal drains in morrison space. Intraoperative data and postoperative data were collected. Pancreatic function assessment.
The primary outcome was assessment the incidence of POPF after isolated Roux PJ and PG. The secondary outcomes were intraoperative blood loss, drain amount,day to resume oral intake hospital stay, operative duration, pancreatic function, postoperative complications delayed gastric emptying,
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Mansoura, Egito, 35111
- Ayman El Nakeeb
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- All periampullary tumour either benign or resectable malignant tumour
Exclusion Criteria:
- locally advanced tumour infiltrating SMA
- Metastasis
- unfit
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Pancreaticogastrostomy group
Standard PD with regional lymphadenectomy was performed.
PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa.
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Standard PD with regional lymphadenectomy was performed.
PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa.
Outros nomes:
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|
Comparador Ativo: Isolated Roux PJ group
Isolated Roux PJ group, reconstruction was begun using the transected jejunum and ,which was anastomosed in end to side fashion.
A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ).
The PJ loop was anastomosed to the main loop (20 cm caudal to GJ).
|
Isolated Roux PJ group, reconstruction was begun using the transected jejunum and ,which was anastomosed in end to side fashion.
A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ).
The PJ loop was anastomosed to the main loop (20 cm caudal to GJ).
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative pancreatic fistula (POPF)
Prazo: one year postoperative
|
Postoperative pancreatic fistula was defined as drainage of > 50 ml/d of amylase rich fluid( 3 folds elevation above upper limit of normal in serum)
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one year postoperative
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pancreatic function
Prazo: one year postoperative
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Steatorrhea, blood glucose, fat in stool
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one year postoperative
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Postoperative complications
Prazo: one year postoperative
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Delayed gastric emptying, bile leakage, bleeding PG, bleeding GJ
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one year postoperative
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Operative duration
Prazo: 8 hours
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Operative duration
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8 hours
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hospital stay
Prazo: 5 weeks
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hospital stay,
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5 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ayman El Nakeeb, MD, Mansoura University
Publicações e links úteis
Publicações Gerais
- Sutton CD, Garcea G, White SA, O'Leary E, Marshall LJ, Berry DP, Dennison AR. Isolated Roux-loop pancreaticojejunostomy: a series of 61 patients with zero postoperative pancreaticoenteric leaks. J Gastrointest Surg. 2004 Sep-Oct;8(6):701-5. doi: 10.1016/j.gassur.2004.05.001.
- El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.
- Ballas K, Symeonidis N, Rafailidis S, Pavlidis T, Marakis G, Mavroudis N, Sakantamis A. Use of isolated Roux loop for pancreaticojejunostomy reconstruction after pancreaticoduodenectomy. World J Gastroenterol. 2010 Jul 7;16(25):3178-82. doi: 10.3748/wjg.v16.i25.3178.
- Kaman L, Sanyal S, Behera A, Singh R, Katariya RN. Isolated roux loop pancreaticojejunostomy vs single loop pancreaticojejunostomy after pancreaticoduodenectomy. Int J Surg. 2008 Aug;6(4):306-10. doi: 10.1016/j.ijsu.2008.04.007. Epub 2008 May 8.
- Fragulidis GP, Arkadopoulos N, Vassiliou I, Marinis A, Theodosopoulos T, Stafyla V, Kyriazi M, Karapanos K, Dafnios N, Polydorou A, Voros D, Smyrniotis V. Pancreatic leakage after pancreaticoduodenectomy: the impact of the isolated jejunal loop length and anastomotic technique of the pancreatic stump. Pancreas. 2009 Oct;38(7):e177-82. doi: 10.1097/MPA.0b013e3181b57705.
- Kingsnorth AN. Safety and function of isolated Roux loop pancreaticojejunostomy after Whipple's pancreaticoduodenectomy. Ann R Coll Surg Engl. 1994 May;76(3):175-9.
- Khan AW, Agarwal AK, Davidson BR. Isolated Roux Loop duct-to-mucosa pancreaticojejunostomy avoids pancreatic leaks in pancreaticoduodenectomy. Dig Surg. 2002;19(3):199-204. doi: 10.1159/000064213.
- Ke S, Ding XM, Gao J, Zhao AM, Deng GY, Ma RL, Xin ZH, Ning CM, Sun WB. A prospective, randomized trial of Roux-en-Y reconstruction with isolated pancreatic drainage versus conventional loop reconstruction after pancreaticoduodenectomy. Surgery. 2013 Jun;153(6):743-52. doi: 10.1016/j.surg.2013.02.008. Epub 2013 Apr 16.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pancreatic anastomosis
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