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AzTrials

Gastric AdenocarcinomaEarly Phase 1NCT02287168

Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients

A Early Phase 1 study testing pre-gastrectomy peritoneal washing cytology, post-gastrectomy peritoneal washing cytology and post-lavage peritoneal washing cytology in people with Gastric Adenocarcinoma and Gastric Cancer, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have preventive effect on positive peritoneal cytology occurred during gastrectomy in patients with gastric cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Adenocarcinoma, Gastric Cancer
What is being tested?
pre-gastrectomy peritoneal washing cytology, post-gastrectomy peritoneal washing cytology and post-lavage peritoneal washing cytology
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesTurkey (Türkiye)
Study dates
Oct 2014to Dec 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Endoscopically proven gastric adenocarcinoma
  • Standard gastrectomy and a D2 lymph node dissection;
  • Desire to attend the study protocol

Who cannot join

  • Metastatic or overt peritoneal disseminated cancer
  • Undesired reaction to attend the study protocol

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Bezmialem Vakif University Faculty of Medicine Dept of General Surgery

    Istanbul, 34093

  • Mustafa Hasbahceci

    Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have preventive effect on positive peritoneal cytology occurred during gastrectomy in patients with gastric cancer.

Read the detailed description

Peritoneal dissemination of gastric adenocarcinoma cells is the most frequent cause of death in patients with gastric cancer. Spreading of these cells occur by three routes: direct seeding via infiltration through gastric wall, via blood vessels and via perigastric lymphatic channels disturbed during lymph node dissection. Conversion of negative preoperative peritoneal cytology to positive cytology after curative gastrectomy has been shown by previous studies.

Although extensive intra-operative peritoneal lavage (1 L of physiologic saline 10 times) has been shown to be an effective method to eliminate cancer cell dissemination during surgery, to cause significant improvement in survival after gastrectomy, widespread use of this approach has not existed most probably due to its time consuming technical difficulty. Therefore,intra-operative peritoneal lavage (1 L of physiologic saline 3 times) may be used more frequently during gastric surgery.If it is possible to show effectivity of intra-operative peritoneal lavage using a total of 3 L physiologic saline to eliminate cancer cell dissemination occurred before or after gastric surgery, use of this approach may gain acceptance to decrease risk of peritoneal metastasis.

Being tested
pre-gastrectomy peritoneal washing cytology, post-gastrectomy peritoneal washing cytology, post-lavage peritoneal washing cytology
Keywords
Peritoneal lavage, Dissemination, Gastrectomy, Cytology, Lavage
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pre-gastrectomy peritoneal washing cytologyProcedure or surgery

    sampling of peritoneal washing fluid before gastrectomy

  • post-gastrectomy peritoneal washing cytologyProcedure or surgery

    sampling of peritoneal washing fluid after gastrectomy

  • post-lavage peritoneal washing cytologyProcedure or surgery

    sampling of peritoneal washing fluid after peritoneal lavage

Study groups in NCT02287168
Study groupRoleWhat they receive
dissemination of cancer cellsExperimentalconversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy
Receives: Procedure: pre-gastrectomy peritoneal washing cytology; Procedure: post-gastrectomy peritoneal washing cytology
elimination of cancer cellsExperimentalelimination of peritoneal cancer cells occurred before (pre-gastrectomy peritoneal washing cytology) or after gastrectomy (post-gastrectomy peritoneal washing cytology) by intra operative peritoneal lavage ('post-lavage peritoneal washing cytology)
Receives: Procedure: pre-gastrectomy peritoneal washing cytology; Procedure: post-gastrectomy peritoneal washing cytology; Procedure: post-lavage peritoneal washing cytology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. elimination

    rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery

    Measured: at the operation

Secondary outcomes (1)

  1. dissemination

    rate of conversion of negative cytology results to positive cytology by surgery

    Measured: at the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02287168
Sponsor's protocol ID
GastCancPerLav2014
Status last verified
Mar 2016
First submitted
31 Oct 2014
Last updated
29 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Yu XF, Ren ZG, Xue YW, Song HT, Wei YZ, Li CM. D2 lymphadenectomy can disseminate tumor cells into peritoneal cavity in patients with advanced gastric cancer. Neoplasma. 2013;60(2):174-81. doi: 10.4149/neo_2013_023.

    PubMed 23259786

  • Shimada S, Kuramoto M, Marutsuka T, Yagi Y, Baba H. Adopting extensive intra-operative peritoneal lavage (EIPL) as the standard prophylactic strategy for peritoneal recurrence. Rev Recent Clin Trials. 2011 Sep;6(3):266-70. doi: 10.2174/157488711796575603.

    PubMed 21682671

  • Yamamoto K, Shimada S, Hirota M, Yagi Y, Matsuda M, Baba H. EIPL (extensive intraoperative peritoneal lavage) therapy significantly reduces peritoneal recurrence after pancreatectomy in patients with pancreatic cancer. Int J Oncol. 2005 Nov;27(5):1321-8.

    PubMed 16211228

  • 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.

    PubMed 24287077

  • 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.

    PubMed 19638909

  • Marutsuka T, Shimada S, Shiomori K, Hayashi N, Yagi Y, Yamane T, Ogawa M. Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis. Clin Cancer Res. 2003 Feb;9(2):678-85.

    PubMed 12576435

  • Shimada S, Tanaka E, Marutsuka T, Honmyo U, Tokunaga H, Yagi Y, Aoki N, Ogawa M. Extensive intraoperative peritoneal lavage and chemotherapy for gastric cancer patients with peritoneal free cancer cells. Gastric Cancer. 2002;5(3):168-72. doi: 10.1007/s101200200029.

    PubMed 12378344

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing pre-gastrectomy peritoneal washing cytology, post-gastrectomy peritoneal washing cytology and post-lavage peritoneal washing cytology in people with Gastric Adenocarcinoma and Gastric Cancer, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

elimination (time frame: at the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02287168, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.

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