NCT05829213

Brief Summary

The double-flap technique (DFT) is an effective digestive tract reconstruction method after proximal gastrectomy (PG) to reduce the incidence of postoperative reflux esophagitis. But its clinical application is restricted due to the technical complexity. Our surgical team devise a modified esophagogastric reconstructive method which we term the "arch-bridge-type" reconstruction based on the principle of DFT. The aim of this single-arm prospective study is to assess the safety and feasibility of the "arch-bridge-type" reconstruction after PG.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

3.1 years

First QC Date

March 21, 2023

Last Update Submit

April 12, 2023

Conditions

Proximal Gastric AdenocarcinomaAdenocarcinoma of Esophagogastric JunctionAnastomosis

Outcome Measures

Primary Outcomes (2)

  • Surgical safety

    The incidence of postoperative complications which were graded using the Clavien-Dindo classification system. The postoperative complications include anastomotic leackage, anastomotic stenosis, abdominal bleeding, gastric emptying disorder, pneumonia complications, etc.

    From surgery day to 30 days after surgery

  • Postoperative long-term quality of life (QoL)

    The QoL is evaluated by postgastrectomy symptom assessment scale (PGSAS-45). Postoperative reflux, abdominal pain, postprandial discomfort, dyspepsia, diarrhea, constipation, dumping syndrome, weight change, food intake per meal, frequency of additional meals, digestive ability, daily work ability, and satisfaction with quality of life will be evaluated in PGSAS-45.

    1 year after surgery

Secondary Outcomes (4)

  • Postoperative body weight status

    1 year after surgery

  • Postoperative reflux esophagitis

    1 year after surgery

  • Refinement of surgery

    From surgery day to 30 days after surgery

  • Postoperative hemoglobin

    1 year after surgery

Study Arms (1)

"arch-bridge-type" reconstruction arm

EXPERIMENTAL

In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.

Procedure: "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy

Interventions

"arch-bridge-type" esophagogastric reconstruction after proximal gastrectomyPROCEDURE

1. The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines 2. Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor. 3. Creating the seromuscular flap ("arch-bridge") 4. The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.

"arch-bridge-type" reconstruction arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven proximal gastric cancer or adenocarcinoma of esophagogastric junction
  • diameter of the tumor less than 4cm
  • ECOG performance status score ≤2
  • no distant metastasis
  • informed consent is signed

You may not qualify if:

  • metastatic gastric cancer or metastatic adenocarcinoma of esophagogastric junction
  • remnant gastric cancer
  • patient requires emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziyu Li

Beijing, Beijing Municipality, 100142, China

RECRUITING

Study Officials

  • Ziyu Li, MD PHD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinkui Wang, MD PHD

CONTACT

0086-10-88196606wykchangfeng@pku.edu.cn

Ziyu Li, MD PHD

CONTACT

0086-10-88196605ziyu_li@hsc.pku.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Prof.

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 25, 2023

Study Start

November 1, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)