Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

NCT00628186 | Completed DMC

• 1 other identifier: WP-0501
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Bile Duct Cancer; Ampullary Cancer; Pancreatitis; Duodenal Cancer

Keywords

pancreaticoduodenectomy; stent; pancreaticojejunostomy; hospital stay; complication; pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• the length of hospital stay after pancreaticoduodenectomy

  the day of discharge

Secondary Outcomes (1)

• early and late complications after pancreaticoduodenectomy

  6 months

Study Arms (1)

1

EXPERIMENTAL

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]; Device: internal drainage tube [polyethylene pancreatic drainage tube]

Interventions

external drainage tube [polyethylene pancreatic drainage tube] DEVICE

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.

Also known as: polyethylene pancreatic drainage tube(S/N MD41515)

1

internal drainage tube [polyethylene pancreatic drainage tube] DEVICE

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.

Also known as: polyethylene pancreatic drainage tube(S/N MD41515)

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (1)

Wakayama Medical University , Second Department of Surgery

811-1 Kimiidera, Wakayama, Wakayama, 641-8510, Japan

Location

Related Publications (11)

• 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.

  PMID: 18040618 BACKGROUND

• 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.

  PMID: 18027017 BACKGROUND

• 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.

  PMID: 16794381 BACKGROUND

• 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.

  PMID: 16769538 BACKGROUND

• 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.

  PMID: 16615151 BACKGROUND

• 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.

  PMID: 16495694 BACKGROUND

• 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.

  PMID: 15951940 BACKGROUND

• 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.

  PMID: 15592915 BACKGROUND

• 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.

  PMID: 14769579 BACKGROUND

• 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.

  PMID: 12409831 BACKGROUND

• 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.

  PMID: 20074698 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Bile Duct Neoplasms; Pancreatitis; Duodenal Neoplasms; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Masaji Tani, MD

  Wakayama Medical University, Second Department of Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: March 4, 2008
• Study Start: April 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: February 1, 2008
• Last Updated: January 18, 2010

Record last verified: 2010-01

Locations

JP (1)