Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy
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|ClinicalTrials.gov Identifier: NCT00639314|
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Bile Duct Cancer Ampullary Cancer Duodenal Cancer Pancreatitis||Procedure: pylorus-preserving pancreaticoduodenectomy Procedure: pylorus-resecting pancreaticoduodenectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||March 2011|
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.
- delayed gastric empty after pancreaticoduodenectomy [ Time Frame: 1 month ]
- evaluation of quality of life, early and late complications after pancreaticoduodenectomy [ Time Frame: 2 years ]
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
|Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera|
|Wakayama, Japan, 641-8510|
|Study Director:||Manabu Kawai, MD||Wakayama Medical University, School of Medicine, Second Department of Surgery|