Completed

NCT Number: NCT01787955

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.

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Key information

Conditions

Periampullary Pathology Requiring Pancreaticoduodenectomy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severane hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with periampullary disease who have to be treated by PPPD

pancreatic cancer, distal bile duct cancer, duodenal cancer, and so on.
20 year to 80 year-old patients
In terms of general performance status, the patients with more than 70% of the Karnofsky score or ECOG 0 to 1.

Exclusion criteria

Patients with unresectable or locally advanced and metastatic cancer.
The patient who does not want to take the operation.
The patient with more than 3 of ASA score.
Drug abusers or alcoholics.
Non-compliances
The patient who does not want to participate the clinical trials.
The patients who can not read or understand about informed consent form such as a mentally retarded person, the blind, illiteracy, or foreigner.
The patient who have previous transabdominal surgery
The patient who have to have resection of other organs or vessels other than standard PPPD
The patient who is indicated to laparoscopic PPPD

Treatment and study plan

PPPD with Braun anastomosis

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 PPPD

Procedure

Primary outcomes

Comparison of Delayed gastric emptying syndrome occurrence

Time frame: 10 days after operation

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Feb 11, 2013
Registry last updated: Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.