Trial on the Evaluation of Pylorus-Ring in Pancreaticoduodenectomy - Full Text View

Sponsor:	Wakayama Medical University
Information provided by:	Wakayama Medical University
ClinicalTrials.gov Identifier:	NCT00639314

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:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial on the Evaluation of Pylorus-Ring in Pancreaticoduodenectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Intestinal Cancer Pancreatic Cancer

U.S. FDA Resources

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
Estimated Study Completion Date:	March 2009
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: pylorus-resecting pancreaticoduodenectomy pylorus-preserving resection is division of the pylorus of the stomach
2: Active Comparator	Procedure: pylorus-preserving pancreaticoduodenectomy pylorus-preserving resection is division of the duodenum 4cm distal to the pylorus

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639314

Contacts

Contact: Hiroki Yamaue, MD

+81-73-441-0613

yamaue-h@wakayama-med.ac.jp

Locations

Japan
Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera	Recruiting
Wakayama, Japan, 641-8510
Contact: Hiroki Yamaue, MD +81-73-441-0613 yamaue-h@wakayama-med.ac.jp
Principal Investigator: Manabu Kawai, MD

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:

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. Epub 2007 Nov 30.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Wakayama Medical University ( Second Department of Surgery )
Study ID Numbers:	WP-0502
Study First Received:	March 14, 2008
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00639314 History of Changes
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:

Biliary Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine System Diseases
Intestinal Diseases
Intestinal Neoplasms
Duodenal Neoplasms
Neoplasms
Neoplasms by Site

Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Bile Duct Neoplasms
Pancreatitis
Duodenal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009