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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Tata Memorial Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00447746
First received: March 14, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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
Gastric Cancer
Procedure: D1 or D2 lymphadenectomy for gastric cancer patients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • 5 year overall survival

Secondary Outcome Measures:
  • : 5 year disease free survival
  • : 5 year local recurrence
  • : Postoperative morbidity and mortality rates

Estimated Enrollment: 600
Study Start Date: March 2007
Estimated Study Completion Date: March 2014
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447746

Contacts
Contact: Dr Parul J Shukla, M.S.,FRCS +912224177172 pjshukla@hotmail.com
Contact: Dr Shailesh v Shrikhande, M.S. +912224177173

Locations
India
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
Investigators
Principal Investigator: Dr Parul J Shukla, M.S.,FRCS Tata Memorial Centre,Mumbai
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447746     History of Changes
Other Study ID Numbers: TMH 262
Study First Received: March 14, 2007
Last Updated: March 14, 2007
Health Authority: Hospital Scientific Committee,Tata Memorial Centre Mumbai,India:
Hospital Ethics Committee Tata Memorial Centre Mumbai,India:

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 18, 2014