CClinicalTrials.gg
Status unknownNCT02930278Updated Feb 5, 2020

The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy

An observational study in Stomach Neoplasms, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Fujian Medical University · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.

Read the detailed description

A prospective cohort study will be performed to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.The evaluation parameters are perioperative clinical efficacy, postoperative complications and 3-year survival and recurrence rates.

02

Conditions studied

  • Stomach Neoplasms

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 400 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who undergoing laparoscopic radical gastrectomy for gastric cancer are included.

Inclusion criteria

  • Age from 18 to 75 years
  • Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 envelop important vessels
  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 3-year disease overall survival rate

    Time frame: 36 months

Secondary outcomes

  1. overall postoperative morbidity rates

    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

    Time frame: 30 days

  2. 3-year disease free survival rate

    Time frame: 36 months

  3. 3-year recurrence pattern

    Time frame: 36 months

  4. Time to first ambulation

    The data of postoperative recovery course.

    Time frame: 10 days

  5. The number of lymph node dissection

    Time frame: 1 day

  6. The variation of weight

    The variation of weight on postoperative 3, 6, 9 and 12 months

    Time frame: 12 months

  7. The daily highest body temperature

    The daily highest body temperature before discharge

    Time frame: 7 day

  8. Time to first flatus

    Time frame: 10 days

  9. Time to first liquid diet

    Time frame: 10 days

  10. Time to soft diet

    Time frame: 10 days

  11. Duration of hospital stay

    Time frame: 10 days

  12. Intraoperative lymph node dissection time

    intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis.

    Time frame: 1 days

  13. The amount of abdominal drainage

    Time frame: 10 days

  14. Blood transfusion

    Time frame: 10 days

  15. The number of positive lymph nodes

    Time frame: 1 day

  16. Intraoperative morbidity rates

    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

    Time frame: 1 day

  17. The rate of conversion to laparotomy

    Time frame: 1 day

  18. The variation of cholesterol

    The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

    Time frame: 12 months

  19. The variation of albumin

    The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

    Time frame: 12 months

  20. The results of endoscopy

    the results of endoscopy on postoperative 3 and 12 months

    Time frame: 12 months

  21. The values of white blood cell count

    The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  22. The values of lymphocyte count

    The values of lymphocyte count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  23. The values of monocyte count

    The values of monocyte count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  24. The values of neutrophil differential count

    The values of neutrophil differential count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  25. The values of platelet count

    The values of platelet count count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  26. The values of hemoglobin

    The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  27. The values of C-reactive protein

    The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  28. The values of prealbumin

    The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

  29. Visual Analog Score for pain

    the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.

    Time frame: 7 days

07

Study locations

1 site
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02930278
Lead sponsor
Fujian Medical University
Responsible party
Chang-Ming Huang, Prof. (Professor, Fujian Medical University) — Principal investigator
First posted
Oct 12, 2016
Start date
Sep 1, 2016
Primary completion
Oct 30, 2017
Completion
Sep 2020 (estimated)
Last update
Feb 5, 2020

Study contacts

Changming Huang, Professor
principal investigator · Fujian Medical University Union Hospital,China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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