Laparoscopic Versus Open Resection of Cancer Stomach

Gastric Cancer Clinical Trial

Official title:

Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789826
• Other study ID #: AssiutU4958
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2020

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic gastrectomy
Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy.
• Open gastrectomy
patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two weeks
Secondary	Mortality	Measured as 30-day mortality rate	30 days post-operative
Secondary	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	Postoperatively with follow-up to one year
Secondary	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.	during surgery, 1 day
Secondary	Duration of Surgery	UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes.	Peri-operatively, 1 day