D2 Versus D1 Gastrectomy of Operable Gastric Cancer

NCT ID: NCT04429841

Last Updated: 2020-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-06-30

Brief Summary

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Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.

Detailed Description

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This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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D1 Gastrectomy

Patients are managed by radical gastrectomy with D1 lymphadenectomy

Radical gastrectomy with D1 lymphadenectomy

Intervention Type PROCEDURE

D2 Gastrectomy

Patients are managed by radical gastrectomy with D2 lymphadenectomy

Radical gastrectomy with D2 lymphadenectomy

Intervention Type PROCEDURE

Interventions

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Radical gastrectomy with D1 lymphadenectomy

Intervention Type PROCEDURE

Radical gastrectomy with D2 lymphadenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years

Exclusion Criteria

* Complicated gastric cancer (obstructed or perforated)
* Irresectable or metastatic disease
* Previous or coexisting cancer
* Prior gastric surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed El Messiry

Assistant professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Elmessiry, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Surgery

Locations

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Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 22312521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15082726 (View on PubMed)

Other Identifiers

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302764

Identifier Type: -

Identifier Source: org_study_id

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