NCT02694081

Brief Summary

The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.

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
100

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2 gastric-cancer

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

January 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 2, 2017

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

January 29, 2016

Last Update Submit

December 29, 2016

Conditions

Gastric Cancer

Keywords

refluxresidueGastric stasisEmptying time

Outcome Measures

Primary Outcomes (3)

  • The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction

    The time of reconstruction operation will be recorded in the operating note by nurses in minutes.

    within 2 hours after surgery

  • change of potential of hydrogen ( pH) in remnant stomach

    In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened

    1-6 days after surgery

  • the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction

    During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.

    within 2 hours after surgery

Secondary Outcomes (2)

  • the number of patients with the complication of Residual food

    6 month after surgery

  • the number of patients with the complication of Reflux esophagitis

    6 month after surgery

Other Outcomes (1)

  • the number of patients with the complication of gastroesophageal reflux disease(GERD)

    6 month after surgery

Study Arms (2)

Uncut Roux-en-Y Reconstruction

EXPERIMENTAL

Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.

Procedure: Uncut Roux-en-Y Reconstruction

Billroth II Reconstruction

ACTIVE COMPARATOR

Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.

Procedure: Billroth II Reconstruction

Interventions

Uncut Roux-en-Y ReconstructionPROCEDURE

All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.

Uncut Roux-en-Y Reconstruction
Billroth II ReconstructionPROCEDURE

All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.

Billroth II Reconstruction

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of distal gastric cancer
  • underwent laparoscopy-assisted distal gastrectomy

You may not qualify if:

  • have simultaneously other cancer
  • have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
  • have upper gastrointestinal surgery
  • can't bear the gastric tube
  • the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Related Publications (1)

  • Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.

    PMID: 38421211DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsGastroesophageal RefluxGastroparesis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Quan Wang, professor

    The First Hospital of Jilin University

    STUDY DIRECTOR

Central Study Contacts

Dong Yang, postgraduate

CONTACT

18243052038714488468@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisted Investigator

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 29, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-07

Locations

CN(1)