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NCT Number: NCT05539105

A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Ping Shu, PHD

CONTACT

[email protected]

021-64041990

About this study

  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Double tract reconstruction

Procedure

Double tract reconstruction would be applied after radical proximal gastrectomy.

Gastric conduit reconstruction

Procedure

Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.

Other reconstructions

Procedure

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Primary outcomes

  1. Reflux esophagitis incidence 1 year after surgery

    Time frame: 1 year

    Reflux esophagitis refers to esophageal erosions and/or esophageal ulcers caused by the reflux of esophageal contents into the esophagus or above (oral mouth, throat, lungs) causing complaints of discomfort and endoscopic manifestations of esophageal mucosal defects.

Secondary outcomes

  1. Morbidity after surgery

    Time frame: 30 days

    Take the total number of patients receiving surgical treatment as the denominator, and the number of patients with intraoperative/postoperative early and late complications during any one and follow-up as the numerator to calculate the proportion;

  2. Body weight(kg) after surgery

    Time frame: 12 months

    Body weight(kg)would be monitored during follow-up after surgery.

  3. Albumin(g/L) after surgery

    Time frame: 12 months

    Albumin(g/L) would be monitored during follow-up after surgery.

  4. Hemoglobin(g/L) after surgery

    Time frame: 12 months

    Hemoglobin(g/L) would be monitored during follow-up after surgery.

  5. 3-year relapse free survival rate

    Time frame: 3 years

    The time between the date of surgery as the starting point and the date of tumor recurrence as the ending point (or the date of death due to tumor cause when the exact date of tumor recurrence is not known).

    When neither death nor tumor recurrence was observed at follow-up, the final date of confirmation of recurrence-free survival (final recurrence-free survival confirmation date: the last of the date of the outpatient visit or the date of the examination received) was used.

  6. Mortality after surgery

    Time frame: 30 days

    Taking the total number of patients receiving surgical treatment as the denominator, and observing any of the following patients as the numerator, the ratio calculated as the surgical death ratio:

    • According to the observation items during the operation and the observation items after the operation, it will be recorded as death;
    • All patients who died from the start of the operation to within 30 days after the operation (including 30 days) (regardless of whether the cause of death was causally related to the operation);
    • In a longer period of time after 31 days after the operation, there is definite evidence that the death of the patient has a direct causal relationship with the first operation.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Acronym: STAR-PG01

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Sep 14, 2022
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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