An observational study in Gastric Cancer and Gastrostomy, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Peking University · Observational
The real world based multi-cohorts study aims to evaluate the safety and effectiveness of function preserving gastrectomy including pylorus-preserving distal gastrectomy, proximal gastrectomy and wedge gastrectomy for T1 and T2 gastric cancer patients.
Gastric cancer patients with clinical stage T1/2 will be screened for the study. For the patients enrolled, a multidisciplinary discussion will be performed to evaluate the proper gastrectomy for the patients and functional preserving gastrectomy will be considered for the indicated patients. For patients not proper for functional preserving gastrectomy, standard gastrectomies will be suggested. After surgery, a close follow up will be performed. During the study, a thorough data collection will be performed to evaluate the safety and effectiveness of functional preserving gastrectomy and recovery and postoperative function of remnant stomach.
2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's planned enrollment of 300 is close to the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Non-advanced gastric cancer patients with the clinical stage cT1-2 that are indicated for gastrectomy
Exclusion Criteria:
After baseline evaluation, a multidisciplinary discussion will be performed for the patients to choose the proper gastrectomy. For patients indicated for function preserving gastrectomy (including pylorus preserving gastrectomy, proximal gastrectomy, partial gastrectomy), they will receive the function preserving gastrectomy. After the surgery, a close follow up is performed.
Procedure: Function preserving gastrectomy
After baseline evaluation, a multidisciplinary discussion will be performed for the patients to choose the proper gastrectomy. For patients not indicated for function preserving gastrectomy, they will receive standard gastrectomy. After the surgery, a close follow up is performed.
Procedure: Standard gastrectomy
Function preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy.
Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.
R0 resection rate
Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result.
Time frame: 30 days after surgery
Extent of lymphadenectomy of different gastrectomy
resected lymph node number
Time frame: 30 days after surgery
Distribution of metastatic lymph node
metastatic lymph node number
Time frame: 30 days after surgery
postoperative morbidity
postoperative complication rate according to the clavien-dindo classification
Time frame: 30 days after surgery
postoperative mortality
postoperative death rate with 30 days
Time frame: 30 days after surgery
remnant stomach function
volume of remnant stomach
Time frame: 3 years after surgery
disease free survival
disease free survival after surgery
Time frame: 3 years after surgery
Quality of life after surgery
Quality of life evaluated by EORTC-STO22 by questionnaire
Time frame: 3 years after surgery
overall survival
overall survival after surgery
Time frame: 3 years after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University