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Not yet recruitingNCT06934824Updated Apr 18, 2025

Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b

An interventional study of Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und in Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, sponsored by Hebei Medical University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Hebei Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.

02

Conditions studied

  • Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

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03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Hebei Medical University is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18-70 years old;
  2. Endoscopic pathological diagnosis: adenocarcinoma;
  3. Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M0.
  4. Has not received other treatment;
  5. No other serious comorbidities;
  6. Agree to participate in the study and sign the form.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. History of previous abdominal surgery
  3. History of other previous
  4. Can patients with severe heart, lung, brain diseases tolerate surgical treatment
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group A

    Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.

    Procedure: Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

  • Experimental
    Group B

    Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b. Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

    Procedure: Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

Interventions

  • ProcedureSixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

    Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection. Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b. Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

06

What researchers measure

Primary outcomes

  1. Rate of recurrence

    Time frame: Within 2 years

Secondary outcomes

  1. The operation time, complications and hospital stay were recorded

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Dec 2026, 19 months later.

Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 19 months is below that.

Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2025
First posted
Apr 18, 2025
StartEst.
May 1, 2025
Primary completionEst.
Dec 1, 2026
CompletionEst.
Jan 1, 2027
Last update
Apr 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06934824
Lead sponsor
Hebei Medical University
Responsible party
Qun Zhao (Professor, Hebei Medical University) — Principal investigator
First posted
Apr 18, 2025
Start date
May 1, 2025 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Apr 18, 2025

Study contacts

Qun Zhao, Ph.D
Contact
zhaoqun@hebmu.edu.cn
China+8613930162111
Gang pei Yang, Master's degree
Contact
China+8613731153070

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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