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A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy (STAR-PG01)

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ClinicalTrials.gov Identifier: NCT05539105
Recruitment Status : Recruiting
First Posted : September 14, 2022
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Proximal Gastric Adenocarcinoma Reconstruction Procedure: Double tract reconstruction Procedure: Gastric conduit reconstruction Procedure: Other reconstructions

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
Actual Study Start Date : August 22, 2022
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Double tract reconstruction
Double tract reconstruction would be applied after proximal gastrectomy
 Procedure: Double tract reconstruction
Double tract reconstruction would be applied after radical proximal gastrectomy.
Gastric conduit reconstruction
Gastric conduit reconstruction would be applied after proximal gastrectomy
 Procedure: Gastric conduit reconstruction
Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.
Other reconstructions
Other reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy
 Procedure: Other reconstructions
Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. According to the observation items during the operation and the observation items after the operation, it will be recorded as death;
    2. 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);
    3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05539105


Locations
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China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ping Shu, PHD    021-64041990    shu.ping@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
More Information
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT05539105    
Other Study ID Numbers: STAR-PG01
First Posted: September 14, 2022    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
Proximal gastrectomy
Reconstruction
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms