Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00639314
First received: March 14, 2008
Last updated: June 23, 2011
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: March 14, 2008
Last Updated: June 23, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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:
Duodenal Neoplasms
Pancreatic Neoplasms
Pancreatitis
Bile Duct Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014