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Trial Title:
A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
NCT ID:
NCT05539105
Condition:
Proximal Gastric Adenocarcinoma
Reconstruction
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
Proximal gastrectomy
Reconstruction
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Double tract reconstruction
Description:
Double tract reconstruction would be applied after radical proximal gastrectomy.
Arm group label:
Double tract reconstruction
Intervention type:
Procedure
Intervention name:
Gastric conduit reconstruction
Description:
Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.
Arm group label:
Gastric conduit reconstruction
Intervention type:
Procedure
Intervention name:
Other reconstructions
Description:
Other reconstructions except for double tract and gastric conduit reconstructions would
be applied after radical proximal gastrectomy.
Arm group label:
Other reconstructions
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.
Detailed description:
- The patient was admitted to the hospital, and at the time of physical examination,
the following conditions were met: 18 years old ≤ age ≤ 80 years old; preoperative
ECOG performance status score 0/1; non-pregnant or lactating women; no serious
mental illness; no serious respiratory disease; No severe hepatic and renal
insufficiency; no history of unstable angina pectoris and myocardial infarction
within 6 months; no history of cerebral infarction or cerebral hemorrhage within 6
months, except for old cavity infarction; no history of continuous glucocorticoid
therapy (local Except for applications); pulmonary function test showed FEV1 ≥ 50%
of the predicted value. The patient did not participate in other clinical studies
(within 6 months).
- gastric adenocarcinoma was diagnosed by endoscopic examination and
histopathological biopsy of the patient's primary lesion, including: papillary
adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly
adherent carcinoma (including signet ring cell carcinoma and other types),
Mixed adenocarcinoma, etc. In qualified units, endoscopic ultrasonography (EUS)
is recommended. The tumor is located in the upper part of the stomach or at the
esophagogastric junction (tumor diameter is less than 4cm, and the length of
invasion of the esophagus is less than 2cm);
- Enhanced CT scan of the abdomen and pelvis was performed on the patient.
For upper gastric cancer, no tumor invading the muscular layer, subserosal
layer or serosa layer was found, and no distant metastasis occurred; for
esophagogastric junction cancer, no distant metastasis occurred;
- The patient has a clear diagnosis of gastric adenocarcinoma, and it
is expected that proximal gastrectomy and lymph node dissection can
be performed to obtain an R0 surgical result. .
- The patient's ASA is I-III. ⑥ At this point, the patient becomes
a potential selected case and enters the case selection
procedure.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Locations:
Facility:
Name:
Zhongshan Hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Shu, PHD
Phone:
021-64041990
Email:
shu.ping@zs-hospital.sh.cn
Start date:
August 22, 2022
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05539105
