Clinical trial · Interventional

The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.

Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.

NCT06511609CI-TRIAL-00079003not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Proximal Early Gastric Cancer	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
double-flap technique（DFT）; double-tract reconstruction(DTR),	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
double-flap technique（DFT）
description
Laparoscopic proximal gastrectomy with double flap anastomosis group
interventionNames
1. Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),
type
ACTIVE_COMPARATOR
label
double-tract reconstruction（DTR）
description
Laparoscopic proximal gastrectomy with double-tract anastomosis group
interventionNames
1. Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),

Primary outcomes (1)

measure
Proportion of patients with reflux esophagitis
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age between 20 and 80 years, regardless of gender;
2. Patients diagnosed with gastric cancer through tissue biopsy;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. American Society of Anesthesiologists (ASA) classification of I to III;
5. Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:

   Primary tumor located in the upper part of the stomach (proximal 1/3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);
6. Voluntary signing of informed consent.

Exclusion Criteria:

1. Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
2. Presence of contraindications to surgery;
3. Multiple malignant lesions in the stomach;
4. Presence of other malignancies that may affect the preservation of stomach function;
5. Previous upper abdominal surgery (excluding cholecystectomy);
6. Preoperative examination reveals active peptic ulcer;
7. Patients who have received or are currently receiving treatment for systemic inflammatory diseases;
8. Pregnant or breastfeeding women;
9. Conditions deemed unsuitable for participation in this study by the investigator.

References

Publications (0)

Data not yet available

No reference posted for this study.