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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Braun anastomosis group | Experimental |
| |
| conventional group | Active Comparator | conventional Pylorus preserving pancreaticoduodenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPPD with Braun anastomosis | Procedure | making communication between E-loop and A-loop (Braun anastomosis 30cm away from duodenojejunostomy, by using staple method) will be added to conventional PPPD. |
| 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 |
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Inclusion Criteria:
Patients with periampullary disease who have to be treated by PPPD
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severane hospital | Seoul | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22964955 | Background | 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. |
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| conventional PPPD | Procedure |
|