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Trial record 69 of 6674 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03624725
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Xue Yingwei, The Third Affiliated Hospital of Harbin Medical University

Brief Summary:
The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm

Condition or disease Intervention/treatment Phase
Quality of Life Procedure: modified BII+Braun Not Applicable

Detailed Description:
The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified BII+Braun digestive tract reconstruction was superior to the traditional BII+Braun digestive tract reconstruction

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 592 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Controlled Clinical Study of the Effects of Modified and Traditional BII+Braun Digestive Tract Reconstruction Methods on Quality of Life After Radical Gastrectomy for Distal Gastric Cancer
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: modified BII+Braun
The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm
Procedure: modified BII+Braun
modified BII+Braun digestive tract reconstruction

No Intervention: traditional BII+Braun
traditional BII+Braun digestive tract reconstruct



Primary Outcome Measures :
  1. Effects of quality of life [ Time Frame: The quality of life questionnaire was conducted at six months after surgery. ]
    The GSRS scoring system was used to understand the functional status of the digestive tract and its impact on quality of life in postoperative patients .The GSRS scoring system was 0-3, with 0 being the mildest and 3 being the most severe



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18<age<75
  • Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy
  • The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage)
  • It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection
  • Preoperative ECOG performance status score 0/1
  • Nutrition risk screening(NRS2002)
  • Preoperative ASA score I-III
  • Patient informed consent

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Severe mental illness
  • History of upper abdominal surgery
  • History of gastric surgery (including ESD/EMR for gastric cancer)
  • 3 years of history of other malignant diseases;
  • Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment
  • A history of unstable angina or myocardial infarction within 6 months
  • History of cerebral infarction or cerebral hemorrhage within 6 months
  • There is a history of sustained systemic corticosteroid treatment within 1 month
  • Needs simultaneous surgical treatment of other diseases;
  • Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery
  • Pulmonary function test FEV<1 predicted value 50%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624725


Contacts
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Contact: Yan Ma, doctor +8613796655585 doctormayan@163.com

Locations
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China, Helongjiang
Gastrointestinal surgery of the affiated tumor hospital Recruiting
Harbin, Helongjiang, China, 150001
Contact: Yan Ma, doctor         
Sponsors and Collaborators
Xue Yingwei
Investigators
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Study Director: Yingwei Xue, doctor Director of Gastrointestinal surgery

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Responsible Party: Xue Yingwei, Director, Head of Gastrointestinal surgery, Principal Investigator, Clinical Professor, The Third Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03624725     History of Changes
Other Study ID Numbers: 2018-02-R
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xue Yingwei, The Third Affiliated Hospital of Harbin Medical University:
Gastric cancer
Quality of life
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases