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Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639314
First Posted: March 20, 2008
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wakayama Medical University
  Purpose
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).

Condition Intervention
Pancreatic Cancer Bile Duct Cancer Ampullary Cancer Duodenal Cancer Pancreatitis Procedure: pylorus-preserving pancreaticoduodenectomy Procedure: pylorus-resecting pancreaticoduodenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • delayed gastric empty after pancreaticoduodenectomy [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • evaluation of quality of life, early and late complications after pancreaticoduodenectomy [ Time Frame: 2 years ]

Estimated Enrollment: 130
Study Start Date: October 2005
Study Completion Date: March 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring
Procedure: pylorus-preserving pancreaticoduodenectomy
pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus
Active Comparator: 2
In PrPD, the stomach is divided just above the pylorus ring. the nearly total stomach more than 95% was preserved.
Procedure: pylorus-resecting pancreaticoduodenectomy
In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639314


Locations
Japan
Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Investigators
Study Director: Manabu Kawai, MD Wakayama Medical University, School of Medicine, Second Department of Surgery
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00639314     History of Changes
Other Study ID Numbers: WP-0502
First Submitted: March 14, 2008
First Posted: March 20, 2008
Last Update Posted: June 27, 2011
Last Verified: January 2010

Keywords provided by Wakayama Medical University:
pylorus-preserving pancreaticoduodenectomy
pylorus-resecting pancreaticoduodenectomy
randomized controlled trial
delayed gastric empty
quality of life

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Bile Duct Neoplasms
Cholangiocarcinoma
Duodenal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases