Laparoscopic Versus Open Resection of Cancer Stomach

Assiut University

Status: Completed

Conditions: Gastric Cancer

Treatments: Procedure: Open gastrectomy; Procedure: Laparoscopic gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02789826

AssiutU4958

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Laparoscopic gastrectomy

Experimental group

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.

Treatment:

Procedure: Laparoscopic gastrectomy

Open gastrectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Open gastrectomy