Laparoscopic Versus Open Resection of Cancer Stomach

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Open gastrectomy; Procedure: Laparoscopic gastrectomy

• Registration Number: NCT02789826
• Lead Sponsor: Assiut University

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:

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.

Study Timeline

• Study First Submitted: 2016-05-22
• Study First Submitted QC: 2016-05-29
• Study Start: 2016-06
• Study First Posted: 2016-06-03
• Primary Completion: 2019-12
• Study Completion: 2020-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The number of lymph nodes in the postoperative spicement.	two weeks	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

Name	Time	Method
Duration of Surgery	Peri-operatively, 1 day	UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes.
Mortality	30 days post-operative	Measured as 30-day mortality rate
Postoperative complications	Postoperatively with follow-up to one year	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	during surgery, 1 day	Laparoscopic gastrectomy is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and compared to the conventional 'open' group.

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Egypt