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

ConditionsProximal Gastric AdenocarcinomaReconstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Double tract reconstruction

    Procedure/Surgery

    Double tract reconstruction would be applied after radical proximal gastrectomy.

  • Gastric conduit reconstruction

    Procedure/Surgery

    Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.

  • Other reconstructions

    Procedure/Surgery

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

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Double tract reconstruction1 intervention
Group B: Gastric conduit reconstruction1 intervention
Group C: Other reconstructions1 intervention

Trial outcomes

Primary outcomes

1

Reflux esophagitis incidence 1 year after surgery

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.

Time frame
1 year

Secondary outcomes

1

Morbidity after surgery

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;

Time frame
30 days
2

Body weight(kg) after surgery

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

Time frame
12 months
3

Albumin(g/L) after surgery

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

Time frame
12 months
4

Hemoglobin(g/L) after surgery

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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