A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial
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|ClinicalTrials.gov 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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- 5 year overall survival
- : 5 year disease free survival
- : 5 year local recurrence
- : Postoperative morbidity and mortality rates
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 ClinicalTrials.gov identifier (NCT number): NCT00447746
|Contact: Dr Parul J Shukla, M.S.,FRCSemail@example.com|
|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.|
|Principal Investigator:||Dr Parul J Shukla, M.S.,FRCS||Tata Memorial Centre,Mumbai|