Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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.

Conditions
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Periampullary Pathology Requiring Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: PPPD with Braun anastomosis
* Procedure: conventional PPPD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Braun anastomosis group<br> | Procedure: PPPD with Braun anastomosis<br>* making communication between E-loop and A-loop (Braun anastomosis 30cm away from duodenojejunostomy, by using staple method) will be added to conventional PPPD.<br>|
| Active Comparator: conventional group<br>conventional Pylorus preserving pancreaticoduodenectomy | Procedure: conventional PPPD<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Delayed gastric emptying syndrome occurrence | Comparison of DGE occurrence between Braun anastomosis group and conventional Pylorus preserving pancreaticoduodenectomy without Braun anastomosis group | 10 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pylorus preserving pancreaticoduodenectomy(PPPD), Delayed gastric emptying syndrome(DGE), Braun anastomosis