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Trial on the Evaluation of Pylorus-Ring in Pancreaticoduodenectomy
This study is currently recruiting participants.
Study NCT00639314   Information provided by Wakayama Medical University
First Received: March 14, 2008   Last Updated: February 18, 2009   History of Changes

March 14, 2008
February 18, 2009
October 2005
October 2005   (final data collection date for primary outcome measure)
delayed gastric empty after pancreaticoduodenectomy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639314 on ClinicalTrials.gov Archive Site
evaluation of quality of life, early and late complications after pancreaticoduodenectomy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
 
Trial on the Evaluation of Pylorus-Ring in Pancreaticoduodenectomy
Randomized Controlled Trial on the Evaluation of Pylorus-Ring in Pancreaticoduodenectomy

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life (QOL).

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life(QOL)compared with preserving pylorus-ring. Delayed gastric emptying after pancreaticoduodenectomy are important to affect the postoperative course and QOL. However, there is no report that demonstrates the postoperative course between resecting pylorus-ring and preserving pylorus-ring. We conducted a prospective randomized trial on 130 patients who underwent pancreaticoduodenectomy comparing resecting pylorus-ring and preserving pylorus-ring.

The primary endpoint was defined as the decrease of delayed gastric emptying. The secondary endpoints were QOL, mortality and morbidity, including pancreatic fistula, 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 Wakayama Medical University Hospital(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 with a previous gastric resection, and 4) patients without an informed consent.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
  • Pancreatic Cancer
  • Bile Duct Cancer
  • Ampullary Cancer
  • Duodenal Cancer
  • Pancreatitis
  • Procedure: pylorus-preserving pancreaticoduodenectomy
  • Procedure: pylorus-resecting pancreaticoduodenectomy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
130
March 2009
October 2005   (final data collection date for primary outcome measure)

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.
Both
 
No
Contact: Hiroki Yamaue, MD +81-73-441-0613 yamaue-h@wakayama-med.ac.jp
Japan
 
NCT00639314
Second Department of Surgery, Wakayama Medical University
WP-0502
Wakayama Medical University
 
Study Director: Manabu Kawai, MD Wakayama Medical University, School of Medicine, Second Department of Surgery
Wakayama Medical University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP