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Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy

K

Kochi University

Status

Unknown

Conditions

Pancreatic Cancer

Treatments

Procedure: R-Y reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT00906802
RPD Study

Details and patient eligibility

About

One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.

Full description

We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.

Enrollment

40 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass

Exclusion criteria

  • A body weight loss greater than 10% during the six months prior to surgery
  • The presence of distant metastases
  • Seriously impaired function of vital organs due to respiratory, renal or heart disease

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

R-Y reconstruction
Experimental group
Description:
the reconstruction was performed by R-Y anastomosis
Treatment:
Procedure: R-Y reconstruction
conventional reconstruction
No Intervention group
Description:
the anastomosis was performed by B-II

Trial contacts and locations

1

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Central trial contact

Takehiro Okabayashi, MD, PhD; Kazuhiro Hanazaki, Prof

Data sourced from clinicaltrials.gov

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