Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

NCT ID: NCT04340440

Last Updated: 2020-04-10

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

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Randomization by opaque sealed envelopes

Study Groups

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D1 lymphadenectomy

Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy

Group Type ACTIVE_COMPARATOR

D1 lymphadenectomy

Intervention Type PROCEDURE

Radical gastrectomy with D1 lymphadenectomy

D2 lymphadenectomy

Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy

Group Type ACTIVE_COMPARATOR

D2 lymphadenectomy

Intervention Type PROCEDURE

Radical gastrectomy with D2 lymphadenectomy

Interventions

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D1 lymphadenectomy

Radical gastrectomy with D1 lymphadenectomy

Intervention Type PROCEDURE

D2 lymphadenectomy

Radical gastrectomy with D2 lymphadenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Mohamed El Messiry

Ass. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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)

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.

Reference Type BACKGROUND
PMID: 16574546 (View on PubMed)

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)

Other Identifiers

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0302764

Identifier Type: -

Identifier Source: org_study_id

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