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Sponsored by: |
Tata Memorial Hospital |
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Information provided by: | Tata Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00447746 |
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 | Intervention |
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Gastric Cancer |
Procedure: D1 or D2 lymphadenectomy for gastric cancer patients |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Patients with biopsy/frozen section proven adenocarcinoma of stomach.
Exclusion Criteria:Patients with low performance score
Contact: Dr Parul J Shukla, M.S.,FRCS | +912224177172 | pjshukla@hotmail.com |
Contact: Dr Shailesh v Shrikhande, M.S. | +912224177173 |
India, Maharashtra | |
Tata Memorial Hospital,Tata Memorial Centre | |
Mumbai, Maharashtra, India, 400012 |
Principal Investigator: | Dr Parul J Shukla, M.S.,FRCS | Tata Memorial Centre,Mumbai |
Study ID Numbers: | TMH 262 |
Study First Received: | March 14, 2007 |
Last Updated: | March 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00447746 |
Health Authority: | Hospital Scientific Committee,Tata Memorial Centre Mumbai,India:; Hospital Ethics Committee Tata Memorial Centre Mumbai,India: |
Comparison between D1 and D2 lymphadenectomy for gastric cancer |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer |
Neoplasms Neoplasms by Site |