Preliminary Efficacy Analysis of 'λ+α' Double-Tract Reconstruction After Laparoscopic Proximal Gastrectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNorthern Jiangsu People's Hospital

About this trial

The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, based on the stomach's anatomical features and the intercalated jejunum's anti-reflux mechanism, we propose a true dual-channel anastomosis for GI reconstruction, i.e., the "λ+α dual-channel anastomosis". This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "λ+α double-channel anastomosis" in the treatment of early gastric cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • proximal gastrectomy combined with 'λ+α' double-tract anastomosis

    Procedure/Surgery

    1. The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines 2. Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor. 3. The jejunum is dissected 30 cm from the flexor ligament and the distal jejunum is lifted in an anterior colonic direction to the esophageal dissection. 4. Esophagojejunal anastomosis at 16 cm from the distal jejunal stump; 5. Residual gastrojejunostomy at 8 cm from the distal jejunal stump;

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: λ+α double-tract anastomosisExperimental treatment 1 intervention
Group B: double-tract anastomosisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

incidence of reflux esophagitis

The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.

Time frame
12 months after surgery

Secondary outcomes

1

incidence of anastomotic leakage

The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.

Time frame
30 days after surgery
2

incidence of anastomotic stenosis

The percentage (%) of patients developing anastomotic stenosis after surgery in each group.

Time frame
12 months after surgery
3

operative time

The duration, measured in minutes, spent on reconstructing the digestive tract using different reconstruction methods

Time frame
1 day after surgery

Other outcomes

Sponsors and contacts

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