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20 Years
80 Years
Open (Enrolling)
Periampullary Pathology Requiring Pancreaticoduodenectomy

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Trial Information

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

10. The patient who is indicated to laparoscopic PPPD

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Comparison of Delayed gastric emptying syndrome occurrence

Outcome Description:

Comparison of DGE occurrence between Braun anastomosis group and conventional Pylorus preserving pancreaticoduodenectomy without Braun anastomosis group

Outcome Time Frame:

10 days after operation

Safety Issue:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

February 2013

Completion Date:

August 2014

Related Keywords:

  • Periampullary Pathology Requiring Pancreaticoduodenectomy
  • Pylorus preserving pancreaticoduodenectomy(PPPD), Delayed gastric emptying syndrome(DGE), Braun anastomosis
  • Gastroparesis