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

NCT ID: NCT01787955

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-08-31

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.

Conditions

Periampullary Pathology Requiring Pancreaticoduodenectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Braun anastomosis group

Group Type: EXPERIMENTAL

PPPD with Braun anastomosis

Intervention Type: 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.

conventional group

conventional Pylorus preserving pancreaticoduodenectomy

Group Type: ACTIVE_COMPARATOR

conventional PPPD

Intervention Type: PROCEDURE

Interventions

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.

Intervention Type: PROCEDURE

conventional PPPD

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severane hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 22964955 (View on PubMed)

Other Identifiers

4-2012-0879

Identifier Type: -

Identifier Source: org_study_id