NCT05539105

Brief Summary

This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress50%
Aug 2022Dec 2029

Study Start

First participant enrolled

August 22, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

5.4 years

First QC Date

September 8, 2022

Last Update Submit

September 13, 2022

Conditions

Proximal Gastric AdenocarcinomaReconstruction

Keywords

Proximal gastrectomyReconstruction

Outcome Measures

Primary Outcomes (1)

  • Reflux esophagitis incidence 1 year after surgery

    Reflux esophagitis refers to esophageal erosions and/or esophageal ulcers caused by the reflux of esophageal contents into the esophagus or above (oral mouth, throat, lungs) causing complaints of discomfort and endoscopic manifestations of esophageal mucosal defects.

    1 year

Secondary Outcomes (6)

  • Morbidity after surgery

    30 days

  • Body weight(kg) after surgery

    12 months

  • Albumin(g/L) after surgery

    12 months

  • Hemoglobin(g/L) after surgery

    12 months

  • 3-year relapse free survival rate

    3 years

  • +1 more secondary outcomes

Study Arms (3)

Double tract reconstruction

Double tract reconstruction would be applied after proximal gastrectomy

Procedure: Double tract reconstruction

Gastric conduit reconstruction

Gastric conduit reconstruction would be applied after proximal gastrectomy

Procedure: Gastric conduit reconstruction

Other reconstructions

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy

Procedure: Other reconstructions

Interventions

Double tract reconstructionPROCEDURE

Double tract reconstruction would be applied after radical proximal gastrectomy.

Double tract reconstruction
Gastric conduit reconstructionPROCEDURE

Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.

Gastric conduit reconstruction
Other reconstructionsPROCEDURE

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Other reconstructions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is a prospective, multi-center, open, observational, real-world registry study, prospectively and consecutively enrolling patients undergoing proximal gastric surgery in several important gastric cancer across the country. This study emphasizes the continuity of enrolled patients and the breadth of data sources to reflect the real clinical situation. This study plans to include about 10 centers across the country, and plans to enroll consecutive patients who will undergo radical proximal gastrectomy within 2 years. It is expected that a total of 600 prospective registry cases will be included.

You may qualify if:

  • Aged 18-80 years
  • Tumor located in the upper or esophagogastric junction (EGJ), and curative resection with more than 1/2 remant is expected to be achievable by proximal gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
  • Clinical stage T1NxM0 (According to AJCC-8th TNM staging system) of the upper stomach or diameter of EGJ cancer less than 4cm with invading esophgus no more than 2cm without any distant metastasis;
  • Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
  • Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
  • Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
  • Sufficient organ functions
  • Written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 14, 2022

Study Start

August 22, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

CN(1)