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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447746
Recruitment Status : Unknown
Verified March 2007 by Tata Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2007
Last Update Posted : March 15, 2007
Information provided by:
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.

Condition or disease Intervention/treatment
Gastric Cancer Procedure: D1 or D2 lymphadenectomy for gastric cancer patients

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial
Study Start Date : March 2007
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 5 year overall survival

Secondary Outcome Measures :
  1. : 5 year disease free survival
  2. : 5 year local recurrence
  3. : Postoperative morbidity and mortality rates

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447746

Contact: Dr Parul J Shukla, M.S.,FRCS +912224177172
Contact: Dr Shailesh v Shrikhande, M.S. +912224177173

Tata Memorial Hospital,Tata Memorial Centre Not yet recruiting
Mumbai, Maharashtra, India, 400012
Sub-Investigator: Dr K M Mohandas, M.D.         
Sponsors and Collaborators
Tata Memorial Hospital
Principal Investigator: Dr Parul J Shukla, M.S.,FRCS Tata Memorial Centre,Mumbai Identifier: NCT00447746     History of Changes
Other Study ID Numbers: TMH 262
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: March 15, 2007
Last Verified: March 2007

Keywords provided by Tata Memorial Hospital:
Comparison between D1 and D2 lymphadenectomy for gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases