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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00447746
• Other study ID #: TMH 262
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2007
• Last updated: March 14, 2007
• Start date: March 2007
• Est. completion date: March 2014

Study information

• Verified date: March 2007
• Source: Tata Memorial Hospital
• Contact: Dr Parul J Shukla, M.S.,FRCS
• Phone: +912224177172
• Email: pjshukla[@]hotmail.com
• Is FDA regulated: No
• Health authority: Hospital Scientific Committee,Tata Memorial Centre Mumbai,India:Hospital Ethics Committee Tata Memorial Centre Mumbai,India:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• D1 or D2 lymphadenectomy for gastric cancer patients

Locations

Country	Name	City	State
India	Tata Memorial Hospital,Tata Memorial Centre	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 year overall survival
Secondary	: 5 year disease free survival
Secondary	: 5 year local recurrence
Secondary	: Postoperative morbidity and mortality rates