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

NCT ID: NCT00447746

Last Updated: 2007-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

D1 or D2 lymphadenectomy for gastric cancer patients

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Dr Parul J Shukla, M.S.,FRCS

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Centre,Mumbai

Locations

Tata Memorial Hospital,Tata Memorial Centre

Mumbai, Maharashtra, India

Countries

India

Central Contacts

Dr Parul J Shukla, M.S.,FRCS

Role: CONTACT

pjshukla@hotmail.com

+912224177172

Dr Shailesh v Shrikhande, M.S.

Role: CONTACT

+912224177173

Other Identifiers

TMH 262

Identifier Type: -

Identifier Source: org_study_id