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RecruitingNCT04910789Updated Jun 2, 2021

Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

An interventional study of transhiatal/transabdominal approach and thoracoabdominal approach in Adenocarcinoma of Esophagogastric Junction, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-02.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2022, 3 years 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 5 months after the study started (first participant enrolled Dec 2019, registered May 2021).
  • Started Dec 2019; still recruiting 6 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction

Read the detailed description

Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ adenocarcinoma of esophagogastric junction.

Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.

The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.

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Conditions studied

  • Adenocarcinoma of Esophagogastric Junction
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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 312 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 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
No

Inclusion criteria

  • 1.18\~75 years old
  • 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
  • 3.Histological diagnosis of adenocarcinoma
    1. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
  • 5.Informed consent of patients

Exclusion criteria

Exclusion Criteria:

  • 1.Patients with distant metastasis (M1) or invasion of surrounding organs
  • 2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer)
  • 3.History of other malignant tumors within 5 years
  • 4.The researcher believes that the patient is not suitable to participate in the clinical trial
  • 5.Patients who persist in withdrawing from clinical trials
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
312 participants (estimated)

Study arms

  • Experimental
    Thoracoabdominal approach

    Radical surgery should be finished via Thoracoabdominal approach.

    Procedure: thoracoabdominal approach

  • Active comparator
    Transhiatal/transabdominal approach

    Radical surgery should be finished via transhiatal/transabdominal approach.

    Procedure: transhiatal/transabdominal approach

Interventions

  • Proceduretranshiatal/transabdominal approach

    Radical surgery should be finished via transhiatal/transabdominal approach

  • Procedurethoracoabdominal approach

    Radical surgery should be finished via thoracoabdominal approach

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What researchers measure

Primary outcomes

  1. 3-year disease-free survival

    Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up

    Time frame: 3 years after surgery

Secondary outcomes

  1. The rate of R0-resection

    The proportion of patients undergoing radical resection in all surgical patients

    Time frame: About 10 days after surgery

  2. The number of lymph node dissections and the positive

    The number of lymph node dissections and the positive

    Time frame: About 10 days after surgery

  3. The duration of postoperative hospitalization

    Time from end of surgery to discharge

    Time frame: Within 6 months after surgery

  4. The incidences of early postoperative complications

    The incidence of postoperative complications such as pneumonia, pleural effusion, anastomotic stenosis, anastomotic leakage, duodenal stump fistula, pancreatic fistula, abdominal abscess, and deep vein thrombosis (%).

    Time frame: Within 30 days after surgery

  5. The incidence of perioperative mortality

    The incidence of death due to the surgery

    Time frame: Within 30 days after surgery

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Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    Recruiting
08

References and documents

Publications

  • Song Q, Li X, Wu D, Li S, Xie T, Lu Y, Zhang L, Xu Z, Liu L, Guo X, Wang X. The abdominal-transhiatal surgical approach versus the thoracoabdominal surgical approach in Siewert type II adenocarcinoma of the esophagogastric junction: protocol for a multicenter prospective, open, parallel, and randomized controlled trial. BMC Cancer. 2022 Mar 24;22(1):318. doi: 10.1186/s12885-022-09375-w. PubMed 35331180 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04910789
Lead sponsor
Chinese PLA General Hospital
Responsible party
Lin Chen (Prof., Chinese PLA General Hospital) — Principal investigator
First posted
Jun 2, 2021
Start date
Dec 11, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 2, 2021

Study contacts

Xinxin Wang, Dr
Contact
301wxx@sina.com
+8613811858199

Oversight

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

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