- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01859806
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.
연구 개요
상세 설명
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PD resection to either isolated Roux PJ with isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the nurse.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,
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Mansoura, 이집트, 35111
- Ayman El Nakeeb
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All periampullary tumour either benign or resectable malignant tumour
Exclusion Criteria:
- locally advanced tumour infiltrating SMA
- Metastasis
- unfit
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 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.
다른 이름들:
|
활성 비교기: 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).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Postoperative pancreatic fistula (POPF)
기간: one year postoperative
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pancreatic function
기간: 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
기간: 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
기간: 8 hours
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Operative duration
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8 hours
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hospital stay
기간: 5 weeks
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hospital stay,
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5 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ayman El Nakeeb, MD, Mansoura University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Pancreatic anastomosis
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