Know Cancer

or
forgot password

Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy


N/A
N/A
N/A
Not Enrolling
Both
Pancreatic Cancer, Bile Duct Cancer, Ampullary Cancer, Pancreatitis, Duodenal Cancer

Thank you

Trial Information

Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy


This study compared the postoperative hospital stay and complications of lost stent with
external stent after pancreaticoduodenectomy. The complications of pancreaticoduodenectomy
are important to affect the postoperative course, and, a stent tube often places across
pancreaticojejunostomy to reduce complications. However, there is no report that
demonstrates the postoperative course between pancreatic stent types. We conducted a
prospective randomized trial on 100 patients who underwent pancreaticoduodenectomy comparing
external stent and lost stent.

The primary endpoint was defined as postoperative hospital stay. The secondary endpoints
were mortality and morbidity, including pancreatic fistula, delayed gastric emptying,
intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this
study before surgery, on the basis of whether pancreatic head resection was anticipated at
WMUH for pancreatic head and periampullary disease, and appropriate informed consent was
obtained. Exclusion criteria was 1) patients with severe complications which were possible
to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a
physician, 3) patients who could not be placed a pancreatic stent tube, and 4) patients
without an informed consent.


Inclusion Criteria:



- On the basis of whether pancreatic head resection was anticipated at WMUH for
pancreatic head and periampullary disease, and appropriate informed consent was
obtained.

Exclusion Criteria:

- Patients with severe complications which were possible to prolong hospital stay

- Patients who were diagnosed inadequacy for this study by a physician

- Patients who could not be placed a pancreatic stent tube

- Patients without an informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the length of hospital stay after pancreaticoduodenectomy

Outcome Time Frame:

the day of discharge

Safety Issue:

Yes

Principal Investigator

Masaji Tani, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wakayama Medical University, Second Department of Surgery

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

WP-0501

NCT ID:

NCT00628186

Start Date:

April 2005

Completion Date:

February 2008

Related Keywords:

  • Pancreatic Cancer
  • Bile Duct Cancer
  • Ampullary Cancer
  • Pancreatitis
  • Duodenal Cancer
  • pancreaticoduodenectomy
  • stent
  • pancreaticojejunostomy
  • hospital stay
  • complication
  • pancreatic fistula
  • Duodenal Neoplasms
  • Pancreatic Neoplasms
  • Pancreatitis
  • Bile Duct Neoplasms

Name

Location