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

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.

Study Overview

• Status: Completed
• Conditions: Periampullary Pathology Requiring Pancreaticoduodenectomy
• Intervention / Treatment: Procedure: PPPD with Braun anastomosis; Procedure: conventional PPPD

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severane hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Pylorus preserving pancreaticoduodenectomy(PPPD), Delayed gastric emptying syndrome(DGE), Braun anastomosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 4-2012-0879