Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06229197
Other study ID # 2023HXFH005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date December 31, 2027

Study information

Verified date January 2024
Source Sichuan University
Contact Zhaolun Cai, MD, PhD
Phone +86-028-85423610
Email caizhaolun@foxmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 176
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion criteria To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria: 1. Histologically proven stage I-III gastric cancer, evaluated as radically resectable 2. No synchronous or metachronous cancers 3. Patients have signed informed consent forms 4. Age 18-80 years old 5. No malfunction of cardio-pulmonary, liver, and kidney, ECOG score 0-1 6. No emergency surgery needed Exclusion criteria Patients will be excluded according to the following criteria: 1. Pregnant or lactating women 2. Distant metastasis to the liver, lung, bone, supraclavicular lymph nodes, pelvic, or ovarian species and peritoneal dissemination 3. Ascites or cachexia 4. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes 5. Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials 6. Mental illness 7. Surgical history whose influence has not been eliminated 8. History of another gastric or esophageal malignancy, including stromal tumor, sarcoma, lymphoma, and carcinoid 9. Active infection with a fever of over 38°C 10. Poor compliance 11. Not suitable for this trial because of other clinical or laboratory conditions determined by the researchers

Study Design


Intervention

Procedure:
Billroth II reconstruction
Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant
Braun Anastomosis
This is an additional surgical connection (anastomosis) created between two parts of the small intestine, specifically between the afferent (incoming) and efferent (outgoing) limbs of the jejunum near the gastrojejunostomy (the new connection between the stomach and small intestine created during a Billroth II procedure).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sichuan University

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of reflux gastritis assessed according to RGB classification by endoscopic evaluation 6 months, 12 months
Secondary Quality of life assessed by the PGSAS-45 Scale The preoperative and postoperative QoL of patients between the two groups. 6 months, 12 months
Secondary Nutritional status Changes in body weight (kg) or BMI from baseline 6 months, 12 months
Secondary Time to first passage of flatus/stool Time taken to pass first stool or flatus within 30 days after surgery
Secondary Postoperative complications (assessed according to the Clavien-Dindo) e.g., anastomotic leakage, anastomotic bleeding assessed by laboratory test in combination with clinical features, radiological diagnostic methods, endoscopy, diagnostic laparoscopy. within 30 days after surgery
Secondary Long-term complications e.g., food residue and bile reflux (assessed according to the RGB classification). 6 months, 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2