NCT02140034

Brief Summary

This study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started May 2013

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

3 years

First QC Date

May 14, 2014

Last Update Submit

May 15, 2014

Conditions

Gastric Cancer

Keywords

Extensive Peritoneal LavageOverall SurvivalDisease Free SurvivalPeritoneal Recurrence RateT3 and T4 Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    3 years

Secondary Outcomes (2)

  • Disease Free Survival

    3 years

  • Peritoneal Recurrence Rate

    3 years

Study Arms (2)

Study Arm: Extensive Peritoneal Lavage

EXPERIMENTAL

The peritoneal cavity of subject will be washed with 10 liters of warmed normal saline (1 liter per cycle for 10 cycles) . The abdomen will be closed as per standard

Procedure: Extensive Peritoneal Lavage

Control Arm: Standard Treatment

NO INTERVENTION

The peritoneal cavity of subjects will be washed with 2 liters or less of warmed normal saline. The abdomen will be closed as per standard.

Interventions

Extensive Peritoneal LavagePROCEDURE
Study Arm: Extensive Peritoneal Lavage

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer.
  • Patients planned for open or laparoscopic gastrectomy.
  • Patients undergoing gastrectomy with curative intent.
  • Lower age limit of research subjects 21 years old and upper age limit of 80 years old.
  • Ability to provide informed consent

You may not qualify if:

  • Patients who undergo a palliative gastrectomy.
  • Patients who undergo a gastrectomy as emergency.
  • Vulnerable persons under age of 21.
  • Patients receiving neoadjuvant therapy.
  • Patients presented with life-threatening bleeding from tumour
  • ASA score of 4 \& 5
  • Patients with another primary cancer within last 5 years
  • Patients with gross peritoneal and liver metastasis at surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

Related Publications (3)

  • Misawa K, Mochizuki Y, Ohashi N, Matsui T, Nakayama H, Tsuboi K, Sakai M, Ito S, Morita S, Kodera Y. A randomized phase III trial exploring the prognostic value of extensive intraoperative peritoneal lavage in addition to standard treatment for resectable advanced gastric cancer: CCOG 1102 study. Jpn J Clin Oncol. 2014 Jan;44(1):101-3. doi: 10.1093/jjco/hyt157. Epub 2013 Nov 27.

    PMID: 24287077BACKGROUND

  • Kuramoto M, Shimada S, Ikeshima S, Matsuo A, Yagi Y, Matsuda M, Yonemura Y, Baba H. Extensive intraoperative peritoneal lavage as a standard prophylactic strategy for peritoneal recurrence in patients with gastric carcinoma. Ann Surg. 2009 Aug;250(2):242-6. doi: 10.1097/SLA.0b013e3181b0c80e.

    PMID: 19638909BACKGROUND

  • Yang HK, Ji J, Han SU, Terashima M, Li G, Kim HH, Law S, Shabbir A, Song KY, Hyung WJ, Kosai NR, Kono K, Misawa K, Yabusaki H, Kinoshita T, Lau PC, Kim YW, Rao JR, Ng E, Yamada T, Yoshida K, Park DJ, Tai BC, So JBY; EXPEL study group. Extensive peritoneal lavage with saline after curative gastrectomy for gastric cancer (EXPEL): a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):120-127. doi: 10.1016/S2468-1253(20)30315-0. Epub 2020 Nov 27.

    PMID: 33253659DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jimmy So, MBChB

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmy So, MBChB

CONTACT

+65 6772 5555sursbyj@nus.edu.sg

Amy Tay, Nursing

CONTACT

+65 6772 5555surtyla@nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

SG(1)