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Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer

NCT ID: NCT02969148

Last Updated: 2016-11-21

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2024-11-30

Brief Summary

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To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.

Detailed Description

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To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.

Conditions

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Gastric Cancer Stage II Gastric Cancer Stage III

Keywords

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Laparoscopic Bursectomy D2 lymphadenectomy Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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The bursectomy and D2 lymphadenectomy

Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN)

Group Type EXPERIMENTAL

Laparoscopic bursectomy and D2 lymphadenectomy

Intervention Type PROCEDURE

The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.

The D2 lymphadenectomy

Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis.

Group Type ACTIVE_COMPARATOR

Laparoscopic D2 lymphadenectomy

Intervention Type PROCEDURE

D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).

Interventions

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Laparoscopic bursectomy and D2 lymphadenectomy

The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.

Intervention Type PROCEDURE

Laparoscopic D2 lymphadenectomy

D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. The age limits is 18-80 years old;
2. T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.
3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;
4. American Society of anesthesiologists (ASA) score less than or equal to Level 3;
5. Criteria of performance status karnofsky is greater than or equal to 60.

Exclusion Criteria

1. The patients' age limits is Less than 18 years old, or more than 80 years old;
2. The preoperative imaging confirmed that the tumor involve adjacent organs;
3. The tumor have been finding distant metastases;
4. American Society of anesthesiologists (ASA) score more than 3;
5. Criteria of performance status karnofsky is lower than 60;
6. There is a laparoscopic surgery contraindications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jin Wan

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Wan, professor

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Liao-nan Zou, professor

Role: STUDY_DIRECTOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin Wan, professor

Role: CONTACT

Phone: 0086-020-13710637721

Email: [email protected]

Liao-nan Zou, professor

Role: CONTACT

Phone: 0086-020-13423663496

Email: [email protected]

Facility Contacts

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liao-nan Zou, professor

Role: primary

xin-quan Lu, Dr

Role: backup

References

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Zou LN, He YB, Li HM, Diao DC, Mo DL, Wang W, Wan J. Surgical skills for laparoscopic resection of the bursa omentalis and lymph node scavenging with radical gastrectomy. Oncol Lett. 2015 Jul;10(1):99-102. doi: 10.3892/ol.2015.3226. Epub 2015 May 19.

Reference Type RESULT
PMID: 26170983 (View on PubMed)

Zou L, Xiong W, Mo D, Chen G, He Y, Li H, Tan P, Wang W, Wan J. Totally laparoscopic complete bursectomy and D2 lymphadenectomy in radical total gastrectomy: an outside bursa omentalis approach. Surg Endosc. 2016 Sep;30(9):4152. doi: 10.1007/s00464-015-4702-z. Epub 2015 Dec 16.

Reference Type RESULT
PMID: 26675932 (View on PubMed)

Other Identifiers

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LBDL1

Identifier Type: -

Identifier Source: org_study_id