Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy
Primary Purpose
Pancreatic Cancer, Bile Duct Cancer, Ampullary Cancer
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
pylorus-preserving pancreaticoduodenectomy
pylorus-resecting pancreaticoduodenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pylorus-preserving pancreaticoduodenectomy, pylorus-resecting pancreaticoduodenectomy, randomized controlled trial, delayed gastric empty, quality of life
Eligibility 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.
Sites / Locations
- Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring
In PrPD, the stomach is divided just above the pylorus ring. the nearly total stomach more than 95% was preserved.
Outcomes
Primary Outcome Measures
delayed gastric empty after pancreaticoduodenectomy
Secondary Outcome Measures
evaluation of quality of life, early and late complications after pancreaticoduodenectomy
Full Information
NCT ID
NCT00639314
First Posted
March 14, 2008
Last Updated
June 23, 2011
Sponsor
Wakayama Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00639314
Brief Title
Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy
Official Title
Randomized Controlled Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wakayama Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Bile Duct Cancer, Ampullary Cancer, Duodenal Cancer, Pancreatitis
Keywords
pylorus-preserving pancreaticoduodenectomy, pylorus-resecting pancreaticoduodenectomy, randomized controlled trial, delayed gastric empty, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring
Arm Title
2
Arm Type
Active Comparator
Arm Description
In PrPD, the stomach is divided just above the pylorus ring. the nearly total stomach more than 95% was preserved.
Intervention Type
Procedure
Intervention Name(s)
pylorus-preserving pancreaticoduodenectomy
Intervention Description
pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus
Intervention Type
Procedure
Intervention Name(s)
pylorus-resecting pancreaticoduodenectomy
Intervention Description
In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.
Primary Outcome Measure Information:
Title
delayed gastric empty after pancreaticoduodenectomy
Time Frame
1 month
Secondary Outcome Measure Information:
Title
evaluation of quality of life, early and late complications after pancreaticoduodenectomy
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manabu Kawai, MD
Organizational Affiliation
Wakayama Medical University, School of Medicine, Second Department of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
18040618
Citation
Tani M, Kawai M, Terasawa H, Ina S, Hirono S, Shimamoto T, Miyazawa M, Uchiyama K, Yamaue H. Prognostic factors for long-term survival in patients with locally invasive pancreatic cancer. J Hepatobiliary Pancreat Surg. 2007;14(6):545-50. doi: 10.1007/s00534-007-1209-6. Epub 2007 Nov 30.
Results Reference
background
PubMed Identifier
18027017
Citation
Kawai M, Tani M, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Shimamoto T, Yamaue H. CLIP method (preoperative CT image-assessed ligation of inferior pancreaticoduodenal artery) reduces intraoperative bleeding during pancreaticoduodenectomy. World J Surg. 2008 Jan;32(1):82-7. doi: 10.1007/s00268-007-9305-y.
Results Reference
background
PubMed Identifier
16794381
Citation
Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.
Results Reference
background
PubMed Identifier
16769538
Citation
Terasawa H, Uchiyama K, Tani M, Kawai M, Tsuji T, Tabuse K, Kobayashi Y, Taniguchi K, Yamaue H. Impact of lymph node metastasis on survival in patients with pathological T1 carcinoma of the ampulla of Vater. J Gastrointest Surg. 2006 Jun;10(6):823-8. doi: 10.1016/j.gassur.2006.01.013.
Results Reference
background
PubMed Identifier
16615151
Citation
Tani M, Kawai M, Terasawa H, Ina S, Hirono S, Uchiyama K, Yamaue H. Does postoperative chemotherapy have a survival benefit for patients with pancreatic cancer? J Surg Oncol. 2006 May 1;93(6):485-90. doi: 10.1002/jso.20440.
Results Reference
background
PubMed Identifier
16495694
Citation
Tani M, Terasawa H, Kawai M, Ina S, Hirono S, Uchiyama K, Yamaue H. Improvement of delayed gastric emptying in pylorus-preserving pancreaticoduodenectomy: results of a prospective, randomized, controlled trial. Ann Surg. 2006 Mar;243(3):316-20. doi: 10.1097/01.sla.0000201479.84934.ca.
Results Reference
background
PubMed Identifier
15951940
Citation
Tani M, Kawai M, Terasawa H, Ueno M, Hama T, Hirono S, Ina S, Uchiyama K, Yamaue H. Complications with reconstruction procedures in pylorus-preserving pancreaticoduodenectomy. World J Surg. 2005 Jul;29(7):881-4. doi: 10.1007/s00268-005-7697-0.
Results Reference
background
PubMed Identifier
15592915
Citation
Tani M, Onishi H, Kinoshita H, Kawai M, Ueno M, Hama T, Uchiyama K, Yamaue H. The evaluation of duct-to-mucosal pancreaticojejunostomy in pancreaticoduodenectomy. World J Surg. 2005 Jan;29(1):76-9. doi: 10.1007/s00268-004-7507-0.
Results Reference
background
PubMed Identifier
14769579
Citation
Kawai M, Uchiyama K, Tani M, Onishi H, Kinoshita H, Ueno M, Hama T, Yamaue H. Clinicopathological features of malignant intraductal papillary mucinous tumors of the pancreas: the differential diagnosis from benign entities. Arch Surg. 2004 Feb;139(2):188-92. doi: 10.1001/archsurg.139.2.188.
Results Reference
background
PubMed Identifier
12409831
Citation
Yamaue H, Tani M, Onishi H, Kinoshita H, Nakamori M, Yokoyama S, Iwahashi M, Uchiyama K. Locoregional chemotherapy for patients with pancreatic cancer intra-arterial adjuvant chemotherapy after pancreatectomy with portal vein resection. Pancreas. 2002 Nov;25(4):366-72. doi: 10.1097/00006676-200211000-00008.
Results Reference
background
PubMed Identifier
21248633
Citation
Kawai M, Tani M, Hirono S, Miyazawa M, Shimizu A, Uchiyama K, Yamaue H. Pylorus ring resection reduces delayed gastric emptying in patients undergoing pancreatoduodenectomy: a prospective, randomized, controlled trial of pylorus-resecting versus pylorus-preserving pancreatoduodenectomy. Ann Surg. 2011 Mar;253(3):495-501. doi: 10.1097/SLA.0b013e31820d98f1.
Results Reference
derived
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Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy
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