Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy - Full Text View

Sponsor:	Wakayama Medical University
Information provided by:	Wakayama Medical University
ClinicalTrials.gov Identifier:	NCT00628186

Purpose

The purpose of this study is to determine which stent type is effective in the decrease of postoperative stay and complications across pancreaticojejunostomy after pancreaticoduodenectomy.

Condition	Intervention
Pancreatic Cancer Bile Duct Cancer Ampullary Cancer Pancreatitis Duodenal Cancer	Device: external drainage tube [polyethylene pancreatic drainage tube] Device: internal drainage tube [polyethylene pancreatic drainage tube]

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:	Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fistulas Intestinal Cancer Pancreatic Cancer Pancreatitis

U.S. FDA Resources

Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:

the length of hospital stay after pancreaticoduodenectomy [ Time Frame: the day of discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

early and late complications after pancreaticoduodenectomy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	April 2005
Study Completion Date:	February 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Pancreaticojejunostomy has a risk factor of pancreatic fistula. Type of stent tube (external stent vs. short stent)across pancreaticojejunostomy was randomized for the patients with pancreaticoduodenectomy.	Device: external drainage tube [polyethylene pancreatic drainage tube] External drainage tube was intubated with a 5F polyethylene pancreatic drainage tube with a small knob (Sumitomo Bakelite Co., Japan)(MD41515) across pancreaticojejunostomy in pancreaticoduodenectomy, and exteriorized through the jejunal limb. Other Name: polyethylene pancreatic drainage tube(S/N MD41515) Device: internal drainage tube [polyethylene pancreatic drainage tube] Internal drainage tube was intubated 5cm length of stent tube cut a 5F polyethylene pancreatic drainage tube with a small knob across pancreaticojejunostomy in pancreaticoduodenectomy, and pancreatic juice was led to reconstructed jejunum. Other Name: polyethylene pancreatic drainage tube(S/N MD41515)

Arms

Assigned Interventions

Experimental: 1

Pancreaticojejunostomy has a risk factor of pancreatic fistula. Type of stent tube (external stent vs. short stent)across pancreaticojejunostomy was randomized for the patients with pancreaticoduodenectomy.

Device: external drainage tube [polyethylene pancreatic drainage tube]

External drainage tube was intubated with a 5F polyethylene pancreatic drainage tube with a small knob (Sumitomo Bakelite Co., Japan)(MD41515) across pancreaticojejunostomy in pancreaticoduodenectomy, and exteriorized through the jejunal limb.

Other Name: polyethylene pancreatic drainage tube(S/N MD41515)

Device: internal drainage tube [polyethylene pancreatic drainage tube]

Internal drainage tube was intubated 5cm length of stent tube cut a 5F polyethylene pancreatic drainage tube with a small knob across pancreaticojejunostomy in pancreaticoduodenectomy, and pancreatic juice was led to reconstructed jejunum.

Other Name: polyethylene pancreatic drainage tube(S/N MD41515)

Detailed Description:

This study compared the postoperative hospital stay and complications of lost stent with external stent after pancreaticoduodenectomy. The complications of pancreaticoduodenectomy are important to affect the postoperative course, and, a stent tube often places across pancreaticojejunostomy to reduce complications. However, there is no report that demonstrates the postoperative course between pancreatic stent types. We conducted a prospective randomized trial on 100 patients who underwent pancreaticoduodenectomy comparing external stent and lost stent.

The primary endpoint was defined as postoperative hospital stay. The secondary endpoints were mortality and morbidity, including pancreatic fistula, delayed gastric emptying, 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 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 who could not be placed a pancreatic stent tube, 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: NCT00628186

Locations

Japan
Wakayama Medical University , Second Department of Surgery
811-1 Kimiidera, Wakayama, Wakayama, Japan, 641-8510

Sponsors and Collaborators

Wakayama Medical University

Investigators

Study Director:

Masaji Tani, MD

Wakayama Medical University, 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tani M, Kawai M, Hirono S, Ina S, Miyazawa M, Shimizu A, Yamaue H. A prospective randomized controlled trial of internal versus external drainage with pancreaticojejunostomy for pancreaticoduodenectomy. Am J Surg. 2010 Jun;199(6):759-64. Epub 2010 Jan 15.

Responsible Party:	Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier:	NCT00628186 History of Changes
Other Study ID Numbers:	WP-0501
Study First Received:	January 23, 2008
Last Updated:	January 15, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:

pancreaticoduodenectomy
stent
pancreaticojejunostomy

hospital stay
complication
pancreatic fistula

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 February 12, 2012