NCT02289183

Brief Summary

The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

5.9 years

First QC Date

November 4, 2014

Last Update Submit

February 4, 2020

Conditions

Stomach Neoplasms

Keywords

Stomach NeoplasmsLaparoscopyBillroth I Operation

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival rate

    36 months

Secondary Outcomes (7)

  • Morbidity and mortality

    30 days;36 months

  • Intraoperative situation

    1 day

  • Postoperative recovery course

    10 days

  • Postoperative nutritional status and quality of life

    12 months

  • Inflammatory and immune response

    7 days

  • +2 more secondary outcomes

Study Arms (2)

Totally laparoscopic distal gastrectomy

EXPERIMENTAL

The totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy will be performed for the treatment of patients with distal gastric cancer assigned to this group.

Procedure: Totally laparoscopic distal gastrectomy

Laparoscopy-assisted distal gastrectomy

ACTIVE COMPARATOR

The laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis will be performed for the treatment of patients with distal gastric cancer assigned to this group.

Procedure: Laparoscopy-assisted distal gastrectomy

Interventions

Totally laparoscopic distal gastrectomyPROCEDURE

Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy

Totally laparoscopic distal gastrectomy
Laparoscopy-assisted distal gastrectomyPROCEDURE

Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis

Laparoscopy-assisted distal gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 75 years (including 18 and 75 years old)
  • Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

You may not qualify if:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • History of other malignant disease within past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1\<50% of predicted values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Changming Huang, M.D.,Ph.D.

    Fujian Medical University Union Hospital

    STUDY CHAIR

  • Chaohui Zheng, M.D.

    Fujian Medical University Union Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fujian Medical University Union Hospital

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 13, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2023

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)