Back to resultsCurative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
D1 lymphadenectomy
D2 lymphadenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Operable gastric cancer, D2 vs D1 lymphadenectomy, Surgical and Oncologic outcomes
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed gastric carcinoma
- Potentially operable gastric carcinoma without evidence of distant metastasis
Exclusion Criteria:
- Complicated gastric cancer (obstructed or perforated)
- Locally irresectable tumor
- Previous or coexisting cancer
- Prior gastric surgery or neoadjuvant chemotherapy
- Contraindication for major surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
D1 lymphadenectomy
D2 lymphadenectomy
Arm Description
Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy
Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy
Outcomes
Primary Outcome Measures
Postoperative morbidity rate
Frequency of early postoperative complications
Operative mortality rate
Frequency of early postoperative mortality
Secondary Outcome Measures
2 years Recurrence rate
Frequency of tumor recurrence within 2 years after curative surgery
2 years Cancer specific mortality rate
Frequency of patients died because of gastric cancer within 2 years after curative surgery
2 years Disease free survival rate
Percentage of patients survived for 2 years without tumor recurrence
2 years Overall survival rate
Percentage of patients survived for 2 years with/without tumor recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04340440
Brief Title
Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma
Official Title
Surgical and Oncologic Outcomes After Curative D2 vs D1 Gastrectomy in Operable Gastric Carcinoma, A Randomized Controlled Study in Egyptian Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. The aim of the current study was to assess the outcomes of curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.
Detailed Description
80 consecutive patients with potentially operable gastric carcinoma were randomized via concealed envelopes into 2 groups (each included 40 patients), group I managed by radical gastrectomy with D1 lymphadenectomy while group II managed by radical gastrectomy with D2 lymphadenectomy . Both groups were compared regarding postoperative mortality, morbidities, tumor recurrence and 2 years survival rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Operable gastric cancer, D2 vs D1 lymphadenectomy, Surgical and Oncologic outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Randomization by opaque sealed envelopes
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D1 lymphadenectomy
Arm Type
Active Comparator
Arm Description
Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy
Arm Title
D2 lymphadenectomy
Arm Type
Active Comparator
Arm Description
Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
D1 lymphadenectomy
Intervention Description
Radical gastrectomy with D1 lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
D2 lymphadenectomy
Intervention Description
Radical gastrectomy with D2 lymphadenectomy
Primary Outcome Measure Information:
Title
Postoperative morbidity rate
Description
Frequency of early postoperative complications
Time Frame
30 days after surgery
Title
Operative mortality rate
Description
Frequency of early postoperative mortality
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
2 years Recurrence rate
Description
Frequency of tumor recurrence within 2 years after curative surgery
Time Frame
2 years after surgery
Title
2 years Cancer specific mortality rate
Description
Frequency of patients died because of gastric cancer within 2 years after curative surgery
Time Frame
2 years after surgery
Title
2 years Disease free survival rate
Description
Percentage of patients survived for 2 years without tumor recurrence
Time Frame
2 years after surgery
Title
2 years Overall survival rate
Description
Percentage of patients survived for 2 years with/without tumor recurrence
Time Frame
2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed gastric carcinoma
Potentially operable gastric carcinoma without evidence of distant metastasis
Exclusion Criteria:
Complicated gastric cancer (obstructed or perforated)
Locally irresectable tumor
Previous or coexisting cancer
Prior gastric surgery or neoadjuvant chemotherapy
Contraindication for major surgery
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15082726
Citation
Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.
Results Reference
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PubMed Identifier
16574546
Citation
Wu CW, Hsiung CA, Lo SS, Hsieh MC, Chen JH, Li AF, Lui WY, Whang-Peng J. Nodal dissection for patients with gastric cancer: a randomised controlled trial. Lancet Oncol. 2006 Apr;7(4):309-15. doi: 10.1016/S1470-2045(06)70623-4.
Results Reference
background
PubMed Identifier
22312521
Citation
Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14.
Results Reference
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Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma
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