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Laparoscopic Versus Open Resection of Cancer Stomach

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic gastrectomy
Open gastrectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Assiut university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic gastrectomy

Open gastrectomy

Arm Description

Patients 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.

Patients allocated to the 'Open Gastrectomy' group will receive gastrectomy via laparotomy. This group is considered the control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality
Measured as 30-day mortality rate
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
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.
Duration of Surgery
UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes.

Full Information

First Posted
May 22, 2016
Last Updated
September 6, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02789826
Brief Title
Laparoscopic Versus Open Resection of Cancer Stomach
Official Title
Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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: laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Laparoscopic gastric cancer resection
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic gastrectomy
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
Open gastrectomy
Arm Type
Active Comparator
Arm Description
Patients allocated to the 'Open Gastrectomy' group will receive gastrectomy via laparotomy. This group is considered the control group
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastrectomy
Other Intervention Name(s)
Minimally invasive gastrectomy
Intervention Description
Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy.
Intervention Type
Procedure
Intervention Name(s)
Open gastrectomy
Intervention Description
patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy
Primary Outcome Measure Information:
Title
The number of lymph nodes in the postoperative spicement.
Description
considered a prognostic factor for disease-free postoperative survival The more the number of lymph nodes the more radicality of the procesure
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Mortality
Description
Measured as 30-day mortality rate
Time Frame
30 days post-operative
Title
Postoperative complications
Description
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
Time Frame
Postoperatively with follow-up to one year
Title
Peri-operative blood loss
Description
Laparoscopic gastrectomy is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and compared to the conventional 'open' group.
Time Frame
during surgery, 1 day
Title
Duration of Surgery
Description
UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes.
Time Frame
Peri-operatively, 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa A Hamad, Prof.
Organizational Affiliation
Assiut University- Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mostafa M Sayed
Organizational Affiliation
Assiut University- Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed G Taher
Organizational Affiliation
Assiut University- Faculty of Medicine- General surgery department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic Versus Open Resection of Cancer Stomach

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