search
Back to results

Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

Primary Purpose

Pancreatic Cancer, Bile Duct Cancer, Ampullary Cancer

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
external drainage tube [polyethylene pancreatic drainage tube]
internal drainage tube [polyethylene pancreatic drainage tube]
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreaticoduodenectomy, stent, pancreaticojejunostomy, hospital stay, complication, pancreatic fistula

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Wakayama Medical University , Second Department of Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

the length of hospital stay after pancreaticoduodenectomy

Secondary Outcome Measures

early and late complications after pancreaticoduodenectomy

Full Information

First Posted
January 23, 2008
Last Updated
January 15, 2010
Sponsor
Wakayama Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT00628186
Brief Title
Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy
Official Title
Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
February 2008 (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 determine which stent type is effective in the decrease of postoperative stay and complications across pancreaticojejunostomy after pancreaticoduodenectomy.
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.

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, Pancreatitis, Duodenal Cancer
Keywords
pancreaticoduodenectomy, stent, pancreaticojejunostomy, hospital stay, complication, pancreatic fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
external drainage tube [polyethylene pancreatic drainage tube]
Other Intervention Name(s)
polyethylene pancreatic drainage tube(S/N MD41515)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
internal drainage tube [polyethylene pancreatic drainage tube]
Other Intervention Name(s)
polyethylene pancreatic drainage tube(S/N MD41515)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the length of hospital stay after pancreaticoduodenectomy
Time Frame
the day of discharge
Secondary Outcome Measure Information:
Title
early and late complications after pancreaticoduodenectomy
Time Frame
6 months

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
Masaji Tani, MD
Organizational Affiliation
Wakayama Medical University, Second Department of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Wakayama Medical University , Second Department of Surgery
City
811-1 Kimiidera, Wakayama
State/Province
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
20074698
Citation
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. doi: 10.1016/j.amjsurg.2009.04.017. Epub 2010 Jan 15.
Results Reference
derived

Learn more about this trial

Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

We'll reach out to this number within 24 hrs