Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy
Primary Purpose
Periampullary Pathology Requiring Pancreaticoduodenectomy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PPPD with Braun anastomosis
conventional PPPD
Sponsored by
About this trial
This is an interventional prevention trial for Periampullary Pathology Requiring Pancreaticoduodenectomy focused on measuring Pylorus preserving pancreaticoduodenectomy(PPPD), Delayed gastric emptying syndrome(DGE), Braun anastomosis
Eligibility Criteria
Inclusion Criteria:
Patients with periampullary disease who have to be treated by PPPD
- pancreatic cancer, distal bile duct cancer, duodenal cancer, and so on.
- 20 year to 80 year-old patients
- In terms of general performance status, the patients with more than 70% of the Karnofsky score or ECOG 0 to 1.
Exclusion Criteria:
- Patients with unresectable or locally advanced and metastatic cancer.
- The patient who does not want to take the operation.
- The patient with more than 3 of ASA score.
- Drug abusers or alcoholics.
- Non-compliances
- The patient who does not want to participate the clinical trials.
- The patients who can not read or understand about informed consent form such as a mentally retarded person, the blind, illiteracy, or foreigner.
- The patient who have previous transabdominal surgery
- The patient who have to have resection of other organs or vessels other than standard PPPD
- The patient who is indicated to laparoscopic PPPD
Sites / Locations
- Severane hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Braun anastomosis group
conventional group
Arm Description
conventional Pylorus preserving pancreaticoduodenectomy
Outcomes
Primary Outcome Measures
Comparison of Delayed gastric emptying syndrome occurrence
Comparison of DGE occurrence between Braun anastomosis group and conventional Pylorus preserving pancreaticoduodenectomy without Braun anastomosis group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01787955
Brief Title
Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pylorus preserving pancreaticoduodenectomy (PPPD) has been considered as only curative treatment modality for periampullary tumor. High mortality rates after PPPD have been reduced down to 1%. However, postoperative morbidities are still reported around 10 to 20 % even in high volume centers.The delayed gastric emptying syndrome(DGE) is one of major complications after PPPD. Many randomized control studies reported that pylorus preserving method was not related to the occurence of DGE. Thus,we assumed that large amount of biliary and pancreatic juice might affect DGE.
With the aim to prove that the use of Braun anastomosis after PPPD can prevent DGE, the investigators started the recruitment of patients with a periampullary tumors to this clinical trial from february 2013 with the study hypothesis that patients with Braun anastomosis had less DGE than those who only got conventional PPPD.
The investigators have calculated the number of patients necessaries to have statistical significant differences in 60 patients with a rate DGE expected to be higher than 30%.
The study include all the patients that usually arrive to our surgery department and who are indicated to PPPD for the curative treatment of periampullary tumor.
The study is randomized, double blind where the investigators and the patients do not know if the patients are in the Braun anastomosis group or not, and prospectively analyzed. All the clinical and laboratory or radiographic finds relative to the occurrence of DGE are recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Pathology Requiring Pancreaticoduodenectomy
Keywords
Pylorus preserving pancreaticoduodenectomy(PPPD), Delayed gastric emptying syndrome(DGE), Braun anastomosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Braun anastomosis group
Arm Type
Experimental
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
conventional Pylorus preserving pancreaticoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
PPPD with Braun anastomosis
Intervention Description
making communication between E-loop and A-loop (Braun anastomosis 30cm away from duodenojejunostomy, by using staple method) will be added to conventional PPPD.
Intervention Type
Procedure
Intervention Name(s)
conventional PPPD
Primary Outcome Measure Information:
Title
Comparison of Delayed gastric emptying syndrome occurrence
Description
Comparison of DGE occurrence between Braun anastomosis group and conventional Pylorus preserving pancreaticoduodenectomy without Braun anastomosis group
Time Frame
10 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with periampullary disease who have to be treated by PPPD
pancreatic cancer, distal bile duct cancer, duodenal cancer, and so on.
20 year to 80 year-old patients
In terms of general performance status, the patients with more than 70% of the Karnofsky score or ECOG 0 to 1.
Exclusion Criteria:
Patients with unresectable or locally advanced and metastatic cancer.
The patient who does not want to take the operation.
The patient with more than 3 of ASA score.
Drug abusers or alcoholics.
Non-compliances
The patient who does not want to participate the clinical trials.
The patients who can not read or understand about informed consent form such as a mentally retarded person, the blind, illiteracy, or foreigner.
The patient who have previous transabdominal surgery
The patient who have to have resection of other organs or vessels other than standard PPPD
The patient who is indicated to laparoscopic PPPD
Facility Information:
Facility Name
Severane hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22964955
Citation
Nikfarjam M, Houli N, Tufail F, Weinberg L, Muralidharan V, Christophi C. Reduction in delayed gastric emptying following non-pylorus preserving pancreaticoduodenectomy by addition of a Braun enteroenterostomy. JOP. 2012 Sep 10;13(5):488-96. doi: 10.6092/1590-8577/800.
Results Reference
background
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Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy
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