About this trial
The primary goal of clinical treatment is to relieve obstruction, restore oral feeding, improve nutritional status and improve quality of life in patients with advanced gastric cancer outflow tract obstruction. At present, the common surgical treatment for relieving obstruction is traditional gastrojejunostomy. Although the operation can relieve the obstruction, there are problems such as tumor-induced bleeding, anastomotic invasion, and high incidence of delayed gastric emptying after operation. Partitioned gastrojejunostomy effectively relieves obstruction by anastomosis of a part of the stomach to the jejunum, and isolates the tumor from the anastomosis, which is beneficial to food emptying and can reduce the risk of bleeding and anastomotic invasion. The safety and efficacy of these two procedures are still controversial, mainly because previous studies were retrospective studies or included a small sample size or enrolled patients with different pathological characteristics. The purpose of this study was to compare the safety and efficacy of separated and traditional gastrojejunostomy in the treatment of advanced gastric cancer outflow tract obstruction, and to provide the best choice for the treatment of advanced gastric cancer outflow tract obstruction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Unable to comply with the research program or research procedures ;
Patients with other malignant tumors within 5 years before enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ;
Patients with active autoimmune diseases or a history of autoimmune diseases within 4 weeks before enrollment ;
Previously received allogeneic bone marrow transplantation or organ transplantation ;
Trial design
Single group
Treatments tested in this trial
stomach-partitioning gastrojejunostomy
Procedure/SurgeryAt the junction of the gastric body and the antrum, or about 5cm from the upper edge of the tumor, a straight-line cutting closure device was used to cut off part of the gastric body from the greater curvature of the stomach to form a partition, and a 2-3cm wide gastric body near the lesser curvature was retained. A hole was made in the greater curvature of the posterior gastric wall at the proximal end of the septum, and a hole was made in the jejunum-to-mesenteric margin 5-10 cm from the Treitz ligament. A linear cutting closure device was placed through the transverse colon. The greater curvature-jejunum side-to-side anastomosis of the posterior gastric wall with pro-peristalsis or anti-peristalsis was performed, and the common opening was closed by using a linear cutting closure device or suture.
conventional gastrojejunostomy
Procedure/SurgeryThe lowest point of the greater curvature of the stomach and the proximal jejunum 5-10 cm away from the Treitz ligament were subjected to side-to-side anastomosis of peristaltic or anti-peristaltic using a linear cutter before the transverse colon, and the common opening was closed using a linear cutter or suture.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of delayed gastric emptying(DGE)
Percentage of patients with delayed gastric emptying after surgery
Secondary outcomes
PG-SGA score
PG-SGA assessment table contains seven aspects, which are divided into two parts : the patient self-assessment part ( A score ) and the medical staff assessment part ( B + C + D score ). The total score is obtained by adding the two parts.
Early postoperative complication rate
The probability of complications within 21 days after surgery ( including prolonged hospital stay and rehospitalization ).
Late postoperative complication rate
Probability of complications 21 days after surgery
Anastomotic complication rate
The probability of postoperative anastomotic complications including anastomotic stenosis and anastomotic bleeding.
Other outcomes
quality of life (QLQ-STO22)
QLQ-STO22 ( gastric cancer-specific module ) uses a 5-level score ( 1-5 points ). The higher the score, the more severe the symptoms or the worse the quality of life.
Sponsors and contacts
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