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AzTrials

Gastric CancerNCT02789826

Laparoscopic Versus Open Resection of Cancer Stomach

A study testing Laparoscopic gastrectomy and Open gastrectomy in people with Gastric Cancer, run by Assiut University at 1 site in Egypt.

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

The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy). There are two main types of techniques (open \& laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Laparoscopic gastrectomy and Open gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteEgypt
Study dates
Jun 2016to Jan 2020
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0).

Who cannot join

  • Pregnancy.
  • Infiltration to the( pancreas ,liver ,colon or vital vascular structure).
  • Metastasis to the (liver, lung, brain, paraaortic LN involvement).
  • Peritoneal deposit.
  • Surgically unfit patient.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut university hospitals

    Asyut

Other trials in Egypt

About this study

Official title: Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial

The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).

There are two main types of techniques (open \& laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin \& less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision.

So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach.

Read the detailed description

The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).

# Tumor resection;

Will be done by one of the following techniques:

  1. laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour)
  2. Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1):
  • D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of < 1.5 cm in diameter;
  • D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer < 2.0 cm in diameter with only perigastric lymph node metastasis (N1);
  • D2 for early cancer > 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique.
Conditions
Gastric Cancer
Being tested
Laparoscopic gastrectomy, Open gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Laparoscopic gastrectomyProcedure or surgery

    Also called Minimally invasive gastrectomy

    Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy.

  • Open gastrectomyProcedure or surgery

    patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy

Study groups in NCT02789826
Study groupRoleWhat they receive
Laparoscopic gastrectomyExperimentalPatients allocated to the 'laparoscopic Gastrectomy' group will undergo laparoscopic gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one.
Receives: Procedure: Laparoscopic gastrectomy
Open gastrectomyActive comparatorPatients allocated to the 'Open Gastrectomy' group will receive gastrectomy via laparotomy. This group is considered the control group
Receives: Procedure: Open gastrectomy

What is being measured

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

  1. The number of lymph nodes in the postoperative spicement.

    considered a prognostic factor for disease-free postoperative survival The more the number of lymph nodes the more radicality of the procesure

    Measured: two weeks

Secondary outcomes (4)

  1. Mortality

    Measured as 30-day mortality rate

    Measured: 30 days post-operative

  2. Postoperative complications

    Complications will be graded according to the Clavien-Dindo classification, which grades complications with regard to necessary treatment for this complication. Also Long-term complications, such as hernia cicatricialis will be monitored

    Measured: Postoperatively with follow-up to one year

  3. Peri-operative blood loss

    Laparoscopic gastrectomy is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and compared to the conventional 'open' group.

    Measured: during surgery, 1 day

  4. Duration of Surgery

    UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes.

    Measured: Peri-operatively, 1 day

Timeline

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

  1. First posted3 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2019
  4. Study completionJan 2020

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
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Laparoscopic gastric cancer resection
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789826
Sponsor's protocol ID
AssiutU4958
Status last verified
Sep 2020
First submitted
22 May 2016
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic gastrectomy and Open gastrectomy in people with Gastric Cancer, run by Assiut University at 1 site in Egypt.

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 1 inclusion and 5 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. 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.

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?

The number of lymph nodes in the postoperative spicement. (time frame: two weeks). 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 NCT02789826.

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 9 Sep 2020.

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