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

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

Tracking Information

• First Submitted Date: September 8, 2022
• First Posted Date: September 14, 2022
• Last Update Posted Date: September 14, 2022
• Actual Study Start Date: August 22, 2022
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2022)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2022)

• 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;
• Body weight(kg) after surgery [ Time Frame: 12 months ]
  Body weight(kg)would be monitored during follow-up after surgery.
• Albumin(g/L) after surgery [ Time Frame: 12 months ]
  Albumin(g/L) would be monitored during follow-up after surgery.
• Hemoglobin(g/L) after surgery [ Time Frame: 12 months ]
  Hemoglobin(g/L) would be monitored during follow-up after surgery.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
• Official Title: A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
• 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.

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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 36 Months
• Biospecimen: Not Provided
• 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.

Condition

• Proximal Gastric Adenocarcinoma
• Reconstruction

Intervention

• Procedure: Double tract reconstruction
  Double tract reconstruction would be applied after radical proximal gastrectomy.
• Procedure: Gastric conduit reconstruction
  Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.
• Procedure: Other reconstructions
  Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Study Groups/Cohorts

• Double tract reconstruction
  Double tract reconstruction would be applied after proximal gastrectomy
  Intervention: Procedure: Double tract reconstruction
• Gastric conduit reconstruction
  Gastric conduit reconstruction would be applied after proximal gastrectomy
  Intervention: Procedure: Gastric conduit reconstruction
• Other reconstructions
  Other reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy
  Intervention: Procedure: Other reconstructions

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 13, 2022): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2029
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

Eligibility 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:

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05539105
• Other Study ID Numbers: STAR-PG01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Shanghai Zhongshan Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanghai Zhongshan Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai Zhongshan Hospital
• Verification Date: September 2022