Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447746
Status:
UNKNOWN
Last Update Posted:
2007-03-15
First Post:
2007-03-14
Brief Title:
A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer A Prospective Randomized Controlled Trial
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer A Prospective Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric cancer remains the second most common cancer worldwideAlthough 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 seriesThe exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortalityThe extent of surgery and particularly the development of systematic lymphadenectomyD2has 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 survivaldisease free survival and loco regional recurrence and also post operative morbidity and mortality following both these proceduresthis study has been undertaken
In D1 lymphadenectomy only those lymph nodes which are adjacent to the part of stomach being resected will be removedIn 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 otherNeither is any of these procedures experimental
We are doing this trial to see whether one of these procedures is superior to the other
However the results of surgery are generally disapointing in most large seriesThe exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortalityThe extent of surgery and particularly the development of systematic lymphadenectomyD2has 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 survivaldisease free survival and loco regional recurrence and also post operative morbidity and mortality following both these proceduresthis study has been undertaken
In D1 lymphadenectomy only those lymph nodes which are adjacent to the part of stomach being resected will be removedIn 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 otherNeither 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None