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Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy (PD)

Primary Purpose

Pancreatic Fistula After Pancreaticoduodenectomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pancreaticogastrostomy group
Isolated Roux PJ group
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Fistula After Pancreaticoduodenectomy focused on measuring periampullary tumour, isolated Roux loop PJ, PG

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All periampullary tumour either benign or resectable malignant tumour

Exclusion Criteria:

  • locally advanced tumour infiltrating SMA
  • Metastasis
  • unfit

Sites / Locations

  • Ayman El Nakeeb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pancreaticogastrostomy group

Isolated Roux PJ group

Arm Description

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).

Outcomes

Primary Outcome Measures

Postoperative pancreatic fistula (POPF)
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)

Secondary Outcome Measures

Pancreatic function
Steatorrhea, blood glucose, fat in stool
Postoperative complications
Delayed gastric emptying, bile leakage, bleeding PG, bleeding GJ
Operative duration
Operative duration
hospital stay
hospital stay,

Full Information

First Posted
May 14, 2013
Last Updated
May 20, 2013
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01859806
Brief Title
Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy
Acronym
PD
Official Title
Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula After Pancreaticoduodenectomy
Keywords
periampullary tumour, isolated Roux loop PJ, PG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pancreaticogastrostomy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Isolated Roux PJ group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Pancreaticogastrostomy group
Other Intervention Name(s)
Group 1
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Isolated Roux PJ group
Other Intervention Name(s)
Group 2
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postoperative pancreatic fistula (POPF)
Description
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)
Time Frame
one year postoperative
Secondary Outcome Measure Information:
Title
Pancreatic function
Description
Steatorrhea, blood glucose, fat in stool
Time Frame
one year postoperative
Title
Postoperative complications
Description
Delayed gastric emptying, bile leakage, bleeding PG, bleeding GJ
Time Frame
one year postoperative
Title
Operative duration
Description
Operative duration
Time Frame
8 hours
Title
hospital stay
Description
hospital stay,
Time Frame
5 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All periampullary tumour either benign or resectable malignant tumour Exclusion Criteria: locally advanced tumour infiltrating SMA Metastasis unfit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman El Nakeeb, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman El Nakeeb
City
Mansoura
ZIP/Postal Code
35111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
15358331
Citation
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.
Results Reference
background
PubMed Identifier
23494109
Citation
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.
Results Reference
background
PubMed Identifier
20593503
Citation
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.
Results Reference
result
PubMed Identifier
18556251
Citation
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.
Results Reference
result
PubMed Identifier
19730152
Citation
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.
Results Reference
result
PubMed Identifier
7912489
Citation
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.
Results Reference
result
PubMed Identifier
12119522
Citation
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.
Results Reference
result
PubMed Identifier
23601899
Citation
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.
Results Reference
result
Links:
URL
http://www.mans.edu.eg/
Description
Mansoura university, Mansoura, Egypt

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Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy

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