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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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PD resection to either isolated Roux PJ with isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the nurse.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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Mansoura, Egitto, 35111
- Ayman El Nakeeb
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- All periampullary tumour either benign or resectable malignant tumour
Exclusion Criteria:
- locally advanced tumour infiltrating SMA
- Metastasis
- unfit
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
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.
Altri nomi:
|
|
Comparatore attivo: 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).
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative pancreatic fistula (POPF)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pancreatic function
Lasso di tempo: one year postoperative
|
Steatorrhea, blood glucose, fat in stool
|
one year postoperative
|
|
Postoperative complications
Lasso di tempo: one year postoperative
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Delayed gastric emptying, bile leakage, bleeding PG, bleeding GJ
|
one year postoperative
|
|
Operative duration
Lasso di tempo: 8 hours
|
Operative duration
|
8 hours
|
|
hospital stay
Lasso di tempo: 5 weeks
|
hospital stay,
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5 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ayman El Nakeeb, MD, Mansoura University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pancreatic anastomosis
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