A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial

Not Applicable

• Conditions: Gastric Cancer

• Registration Number: NCT00447746
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible.

However the results of surgery are generally disapointing in most large series.The exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortality.The extent of surgery and particularly the development of systematic lymphadenectomy(D2)has been credited in Japan for the improved outcome in patients with gastric cancer.

Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in terms of overall survival,disease free survival and loco regional recurrence and also post operative morbidity and mortality following both these procedures,this study has been undertaken.

In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will also be removed according to internationally accepted guidelines and also include resection of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto its attachment to hepatoduodenal ligament.

Currently both these procedures are widely practised worldwide and there is no definite evidence showing the superiority of one procedure over the other.Neither is any of these procedures experimental.

We are doing this trial to see whether one of these procedures is superior to the other.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-03
• Study Start: 2007-03
• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-14
• Last Update Submitted: 2007-03-14
• Study First Posted: 2007-03-15
• Last Update Posted: 2007-03-15
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Patients with biopsy/frozen section proven adenocarcinoma of stomach.

• Preoperative clinical examination and imaging indicating operable disease.
• Intraoperative exploration indicating operability i.e. no peritoneal deposits,no evidence of para aortic lymphadenopathy,no direct involvement of contiguous organs
• Surgical plan for distal/proximal/total gastrectomy

Exclusion Criteria

Patients with low performance score

• Staging investigations or intraoperative exploration indicating inoperable disease
• Patients medically unfit for major surgery
• Patients who have been given preoperative chemotherapy/chemoradiation.
• Patients with gastroesophageal junction tumours
• Patients unreliable for follow up
• Patients above the age of 70 years
• Past history of malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5 year overall survival

Secondary Outcome Measures

Name	Time	Method
: 5 year disease free survival
: 5 year local recurrence
: Postoperative morbidity and mortality rates

Trial Locations

Locations (1)

Tata Memorial Hospital,Tata Memorial Centre; 🇮🇳 Mumbai, Maharashtra, India