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Superior Efficacy and Safety of the "Bridge Technique" Self-Traction in Endoscopic Submucosal Dissection for Semi-Circumferential Gastric Cardia Neoplasms: A Randomized Controlled Trial

Therapeutic efficacy of the "Bridge Technique" self-traction method for Endoscopic Submucosal Dissection (ESD) of cardiac neoplasm involving more than half the circumference

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119809
Enrollment
Unknown
Registered
2026-03-04
Start date
2020-07-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cardia Neoplasms

Interventions

Conventional ESD(CESD) :The procedure was regularly performed with a single-channel endoscope (GIF-Q260J
Olympus Optical, Tokyo, Japan) with a transparent cap attached. The conventional ESD techniques were previously detailed. Briefly, following the placement of circumferential marking dots outside the l
Anrei Medical Co., Ltd., China). Hemostasis during the procedure was achieved endoscopically using either the knife tip itself or hemostatic forceps.
The "Bridge Technique" self-traction ESD (BT-ESD) :The procedure was regularly performed with a single-channel endoscope (GIF-Q260J
Olympus Optical, Tokyo, Japan) with a transparent cap attached.The mucosal incision around the lesion is performed in the same manner as in conventional ESD. During submucosal dissection in the forwar

Sponsors

The First Hospital of Putian City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years. 2. Pathologically confirmed via endoscopic biopsy as adenoma or early adenocarcinoma (including high-grade intraepithelial neoplasia) of the gastric cardia (defined as within 2 cm distal to the gastroesophageal junction). 3. Lesions meeting absolute or extended ESD indications per the Japanese Gastric Cancer Treatment Guidelines: (1) Non-ulcerative mucosal-layer intestinal-type adenocarcinoma (cT1a stage, any size); (2) Ulcerative mucosal-layer intestinal-type adenocarcinoma =50% (semi-circumferential infiltration); (2) Maximum diameter >=3cm. 5. Preoperative endoscopic ultrasound (EUS) and magnifying endoscopy (ME) confirm infiltration depth meets ESD treatment criteria. 6. Preoperative contrast-enhanced chest and abdominal CT excludes lymph node metastasis and distant metastasis. 7. Written informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1.Evidence of lymph node or distant metastasis on imaging studies. 2.Severe systemic diseases precluding safe anesthesia or endoscopic procedures (e.g., New York Heart Association Class III/IV heart failure, severe respiratory insufficiency). 3.Uncorrected coagulopathy. 4.History of prior gastric surgery involving the cardia region. 5)Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Complete resection rate;Delayed bleeding;

Secondary

MeasureTime frame
procedure duration;resection speed;Intraprocedural bleeding frequency;Intraoperative injection volume(ml); Perforation;infection;Postprocedural stricture;

Countries

China

Contacts

Public ContactLinyun Xue

The First Hospital of Putian City

linyunxue83@163.com+86 188 5090 9922

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 31, 2026