Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Randomized Controlled Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Conditions
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Pancreatic Cancer, Bile Duct Cancer, Ampullary Cancer, Duodenal Cancer, Pancreatitis

Intervention / Treatment
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* Procedure: pylorus-preserving pancreaticoduodenectomy
* Procedure: pylorus-resecting pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring | Procedure: pylorus-preserving pancreaticoduodenectomy<br>* pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus<br>|
| Active Comparator: 2<br>In PrPD, the stomach is divided just above the pylorus ring. the nearly total stomach more than 95% was preserved. | Procedure: pylorus-resecting pancreaticoduodenectomy<br>* In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delayed gastric empty after pancreaticoduodenectomy |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of quality of life, early and late complications after pancreaticoduodenectomy |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pylorus-preserving pancreaticoduodenectomy, pylorus-resecting pancreaticoduodenectomy, randomized controlled trial, delayed gastric empty, quality of life