NCT00639314

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

January 1, 2010

Enrollment Period

3.6 years

First QC Date

March 14, 2008

Last Update Submit

June 23, 2011

Conditions

Pancreatic CancerBile Duct CancerAmpullary CancerDuodenal CancerPancreatitis

Keywords

pylorus-preserving pancreaticoduodenectomypylorus-resecting pancreaticoduodenectomyrandomized controlled trialdelayed gastric emptyquality of life

Outcome Measures

Primary Outcomes (1)

  • delayed gastric empty after pancreaticoduodenectomy

    1 month

Secondary Outcomes (1)

  • evaluation of quality of life, early and late complications after pancreaticoduodenectomy

    2 years

Study Arms (2)

1

EXPERIMENTAL

In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring

Procedure: pylorus-preserving pancreaticoduodenectomy

2

ACTIVE COMPARATOR

In PrPD, the stomach is divided just above the pylorus ring. the nearly total stomach more than 95% was preserved.

Procedure: pylorus-resecting pancreaticoduodenectomy

Interventions

pylorus-preserving pancreaticoduodenectomyPROCEDURE

pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus

1
pylorus-resecting pancreaticoduodenectomyPROCEDURE

In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera

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: 18040618BACKGROUND

  • 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: 18027017BACKGROUND

  • 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: 16794381BACKGROUND

  • 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: 16769538BACKGROUND

  • 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: 16615151BACKGROUND

  • 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: 16495694BACKGROUND

  • 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: 15951940BACKGROUND

  • 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: 15592915BACKGROUND

  • 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: 14769579BACKGROUND

  • 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: 12409831BACKGROUND

  • 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.

    PMID: 21248633DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsBile Duct NeoplasmsDuodenal NeoplasmsPancreatitis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesDuodenal DiseasesIntestinal Diseases

Study Officials

  • Manabu Kawai, MD

    Wakayama Medical University, School of Medicine, 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

March 14, 2008

First Posted

March 20, 2008

Study Start

October 1, 2005

Primary Completion

May 1, 2009

Study Completion

March 1, 2011

Last Updated

June 27, 2011

Record last verified: 2010-01

Locations

JP(1)