Periampullary Pathology Requiring Pancreaticoduodenectomy Clinical Trial
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1. Patients with periampullary disease who have to be treated by PPPD - pancreatic cancer, distal bile duct cancer, duodenal cancer, and so on. 2. 20 year to 80 year-old patients 3. In terms of general performance status, the patients with more than 70% of the Karnofsky score or ECOG 0 to 1. Exclusion Criteria: 1. Patients with unresectable or locally advanced and metastatic cancer. 2. The patient who does not want to take the operation. 3. The patient with more than 3 of ASA score. 4. Drug abusers or alcoholics. 5. Non-compliances 6. The patient who does not want to participate the clinical trials. 7. The patients who can not read or understand about informed consent form such as a mentally retarded person, the blind, illiteracy, or foreigner. 8. The patient who have previous transabdominal surgery 9. The patient who have to have resection of other organs or vessels other than standard PPPD 10. The patient who is indicated to laparoscopic PPPD |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severane hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |