Clinical trial NCT02789826: Laparoscopic Versus Open Resection of Cancer Stomach
Official title: Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Laparoscopic gastric cancer resection
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The number of lymph nodes in the postoperative spicement.
timeFrame: two weeks
Secondary outcomes:
measure: Mortality
timeFrame: 30 days post-operative
measure: Postoperative complications
timeFrame: Postoperatively with follow-up to one year
measure: Peri-operative blood loss
timeFrame: during surgery, 1 day
measure: Duration of Surgery
timeFrame: Peri-operatively, 1 day
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: Assiut University- Faculty of Medicine
name: Mostafa A Hamad, Prof.
role: STUDY_DIRECTOR
affiliation: Assiut University- Faculty of Medicine
name: Mostafa M Sayed
role: STUDY_DIRECTOR
affiliation: Assiut University- Faculty of Medicine- General surgery department
name: Mohamed G Taher
role: PRINCIPAL_INVESTIGATOR
References: