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Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy: (PJ)

Primary Purpose

Pancreatic Anastomotic Leak

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Duct to mucosa PJ group
Invagination PJ group
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Anastomotic Leak focused on measuring pancreaticoduodenectomy, pancreatic fistula

Eligibility Criteria

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

Inclusion Criteria:

-Consecutive patients who were treated by pancreaticoduodenectomy

Exclusion Criteria:

  • Any patients with locally advanced periampullary tumour, metastases
  • Patients received neoadjuvant chemoradiotherapy
  • Patients underwent pancreaticogastrostomy (PG)
  • Patients with advanced liver cirrhosis (Child B or C)
  • Malnutrition
  • Coagulopathy

Sites / Locations

  • Ayman El Nakeeb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Duct to mucosa PJ group

Invagination PJ group

Arm Description

Duct to mucosa PJ was performed by a two layer end to side PJ. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic duct diameter. The inner layer duct to mucosa was performed in eight to twelve stitches with 5/0 prolene. A pancreatic duct stent was inserted during anastomosis to allow easy and accurate suture placement, ensure adequate pancreatic duct exposure, and protect the opposite wall from being inadvertently held by needles then it was removed at the end of anastomosis.

Invagination PJ was performed as an end to side. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic stump diameter. The inner layer was performed with 5/0 prolene between pancreatic parenchyma and mucosa. The duct was taken posteriorly and anteriorly to jejunal mucosa. A pancreatic duct stent was inserted during anastomosis and removed at the end of taking the stitches. Reconstruction was completed by end to side hepaticojejunostomy (retrocolic) and gastrojejunostomy (GJ) (antecolic) end to side manually.

Outcomes

Primary Outcome Measures

POPF
POPF was defined by International Study Group of Pancreatic Fistula (ISGPF) as any measurable volume of fluid on or after POD 3 with amylase content greater than 3 times the serum amylase activity . A pancreatic fistula (PF) were graded according to the ISGPF into Grade A, B, and C according to the clinical course

Secondary Outcome Measures

operative time
time of surgical procedure
hospital stay
postoperative stay
postoperative complications
delayed gastric emptying (DGE), pancreatitis, biliary leakage
Pancreatic function
Pancreatic exocrine function was evaluated clinically. It was assessed by presence or absence of steatorrhae (more than three stool per day, fecal output of > 200 g/d for at least three days, pale or yellow stools, and appearance of stools as pasty or greasy, the need of pancreatic enzymes supplement and studied variation in body weight pre and postoperative (

Full Information

First Posted
May 16, 2014
Last Updated
May 19, 2014
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02142517
Brief Title
Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy:
Acronym
PJ
Official Title
Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and also affect significantly the surgical outcomes . The incidence of POPF after pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and mortality after pancreaticoduodenectomy are usually related to surgical management of the pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues to be a challenge at high volume centers. The variety of reconstruction is a reflection of the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many studies compared both techniques, but their surgical outcomes still unclear.The aim of the study was to assess the effectiveness and surgical outcomes of both techniques of PJ after pancreaticoduodenectomy.
Detailed Description
Consecutive patients who were treated by pancreaticoduodenectomy at Gastroenterology Surgical Center, Mansoura, Egypt Exclusion criteria included any patients with locally advanced periampullary tumour, metastases, patients received neoadjuvant chemoradiotherapy, patients underwent pancreaticogastrostomy (PG), patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy. All patients were subjected to careful history taking, clinical examination, routine laboratory investigation abdominal ultrasound, magnetic resonance cholangiopancreatography , and abdominal computerized tomography . The patients were randomized into two groups: Group I: patients underwent duct to mucosa PJ. Group II: patients underwent invagination PJ. The primary outcome was POPF rate.Secondary outcomes were operative time, operative time needed for reconstruction, length of postoperative hospital stay, postoperative morbidities

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Anastomotic Leak
Keywords
pancreaticoduodenectomy, pancreatic fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duct to mucosa PJ group
Arm Type
Active Comparator
Arm Description
Duct to mucosa PJ was performed by a two layer end to side PJ. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic duct diameter. The inner layer duct to mucosa was performed in eight to twelve stitches with 5/0 prolene. A pancreatic duct stent was inserted during anastomosis to allow easy and accurate suture placement, ensure adequate pancreatic duct exposure, and protect the opposite wall from being inadvertently held by needles then it was removed at the end of anastomosis.
Arm Title
Invagination PJ group
Arm Type
Active Comparator
Arm Description
Invagination PJ was performed as an end to side. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic stump diameter. The inner layer was performed with 5/0 prolene between pancreatic parenchyma and mucosa. The duct was taken posteriorly and anteriorly to jejunal mucosa. A pancreatic duct stent was inserted during anastomosis and removed at the end of taking the stitches. Reconstruction was completed by end to side hepaticojejunostomy (retrocolic) and gastrojejunostomy (GJ) (antecolic) end to side manually.
Intervention Type
Procedure
Intervention Name(s)
Duct to mucosa PJ group
Other Intervention Name(s)
Group 1
Intervention Description
Duct to mucosa PJ was performed by a two layer end to side PJ. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic duct diameter. The inner layer duct to mucosa was performed in eight to twelve stitches with 5/0 prolene. A pancreatic duct stent was inserted during anastomosis to allow easy and accurate suture placement, ensure adequate pancreatic duct exposure, and protect the opposite wall from being inadvertently held by needles then it was removed at the end of anastomosis.
Intervention Type
Procedure
Intervention Name(s)
Invagination PJ group
Other Intervention Name(s)
Group 2
Intervention Description
Invagination PJ was performed as an end to side. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic stump diameter. The inner layer was performed with 5/0 prolene between pancreatic parenchyma and mucosa. The duct was taken posteriorly and anteriorly to jejunal mucosa. A pancreatic duct stent was inserted during anastomosis and removed at the end of taking the stitches. Reconstruction was completed by end to side hepaticojejunostomy (retrocolic) and gastrojejunostomy (GJ) (antecolic) end to side manually.
Primary Outcome Measure Information:
Title
POPF
Description
POPF was defined by International Study Group of Pancreatic Fistula (ISGPF) as any measurable volume of fluid on or after POD 3 with amylase content greater than 3 times the serum amylase activity . A pancreatic fistula (PF) were graded according to the ISGPF into Grade A, B, and C according to the clinical course
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
operative time
Description
time of surgical procedure
Time Frame
up to 10 hours
Title
hospital stay
Description
postoperative stay
Time Frame
up to 60 days
Title
postoperative complications
Description
delayed gastric emptying (DGE), pancreatitis, biliary leakage
Time Frame
up to 90 days
Title
Pancreatic function
Description
Pancreatic exocrine function was evaluated clinically. It was assessed by presence or absence of steatorrhae (more than three stool per day, fecal output of > 200 g/d for at least three days, pale or yellow stools, and appearance of stools as pasty or greasy, the need of pancreatic enzymes supplement and studied variation in body weight pre and postoperative (
Time Frame
up to one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Consecutive patients who were treated by pancreaticoduodenectomy Exclusion Criteria: Any patients with locally advanced periampullary tumour, metastases Patients received neoadjuvant chemoradiotherapy Patients underwent pancreaticogastrostomy (PG) Patients with advanced liver cirrhosis (Child B or C) Malnutrition Coagulopathy
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
356111
Country
Egypt

12. IPD Sharing Statement

Citations:
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
result
PubMed Identifier
14639354
Citation
Bassi C, Falconi M, Molinari E, Mantovani W, Butturini G, Gumbs AA, Salvia R, Pederzoli P. Duct-to-mucosa versus end-to-side pancreaticojejunostomy reconstruction after pancreaticoduodenectomy: results of a prospective randomized trial. Surgery. 2003 Nov;134(5):766-71. doi: 10.1016/s0039-6060(03)00345-3.
Results Reference
result
PubMed Identifier
17895850
Citation
Hayashibe A, Kameyama M. The clinical results of duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy in consecutive 55 cases. Pancreas. 2007 Oct;35(3):273-5. doi: 10.1097/MPA.0b013e3180676dc2.
Results Reference
result
PubMed Identifier
11898041
Citation
Hosotani R, Doi R, Imamura M. Duct-to-mucosa pancreaticojejunostomy reduces the risk of pancreatic leakage after pancreatoduodenectomy. World J Surg. 2002 Jan;26(1):99-104. doi: 10.1007/s00268-001-0188-z. Epub 2001 Nov 26.
Results Reference
result
PubMed Identifier
22773303
Citation
Zhang JL, Xiao ZY, Lai DM, Sun J, He CC, Zhang YF, Chen S, Wang J. Comparison of duct-to-mucosa and end-to-side pancreaticojejunostomy reconstruction following pancreaticoduodenectomy. Hepatogastroenterology. 2013 Jan-Feb;60(121):176-9. doi: 10.5754/hge12496.
Results Reference
result
PubMed Identifier
24238526
Citation
Bai XL, Zhang Q, Masood N, Masood W, Gao SL, Zhang Y, Shahed S, Liang TB. Duct-to-mucosa versus invagination pancreaticojejunostomy after pancreaticoduodenectomy: a meta-analysis. Chin Med J (Engl). 2013 Nov;126(22):4340-7.
Results Reference
result
PubMed Identifier
25682724
Citation
El Nakeeb A, El Hemaly M, Askr W, Abd Ellatif M, Hamed H, Elghawalby A, Attia M, Abdallah T, Abd ElWahab M. Comparative study between duct to mucosa and invagination pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized study. Int J Surg. 2015 Apr;16(Pt A):1-6. doi: 10.1016/j.ijsu.2015.02.002. Epub 2015 Feb 13. Erratum In: Int J Surg. 2018 Mar 21;:
Results Reference
derived
Links:
URL
http://www.mans.edu.eg/
Description
Mansoura university, Mansoura, Egypt

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Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy:

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