Clinical trial NCT01787955: Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periampullary Pathology Requiring Pancreaticoduodenectomy
Keywords: Pylorus preserving pancreaticoduodenectomy(PPPD), Delayed gastric emptying syndrome(DGE), Braun anastomosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Delayed gastric emptying syndrome occurrence
timeFrame: 10 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severane hospital
Study officials:
References:
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.