Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05450835
Status:
RECRUITING
Last Update Posted:
2022-11-04
First Post:
2022-07-01
Brief Title:
Safety of OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Safety of OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method During Laparoscopic Total Gastrectomy Protocol of CLASS15-01 Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OGT
Brief Summary:
Abstract Background Our previous studies have shown OGT method significantly simplified overlap esophagojejunostomy with good short-term outcomes and provided new perspectives for optimizing esophagojejunostomy However the safety and efficiency of OGT method still need evidence of randomized controlled trial
Methods This CLASS15-01 trial is a prospective multicenter randomized controlled open and non-inferiority trial Three hundred and twelve patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into OGT groupn156 and traditional groupn156 The primary purpose of this study is to evaluate the early operative morbidity and mortality of OGT method compared with traditional method for Siewert IIIII esophagogastric junction cancer and gastric cancer The second purpose is to evaluate the success rate of inserting anvil fork into esophageal lumen at first attempt attempts of inserting anvil fork into esophagus time of esophagojejunostomyrecovery course and compare the postoperative hospital stay of the patients enrolled in this study
Discussion This CLASS15-01 trial is the first prospective randomized two-arm controlled study to determine the safety and efficiency of OGT method compared with traditional overlap method Through this trial we hope to show that experienced surgeons can safely perform OGT-assisted overlap esophagojejunostomy for Siewert IIIII esophagogastric junction cancer and gastric cancer
Methods This CLASS15-01 trial is a prospective multicenter randomized controlled open and non-inferiority trial Three hundred and twelve patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into OGT groupn156 and traditional groupn156 The primary purpose of this study is to evaluate the early operative morbidity and mortality of OGT method compared with traditional method for Siewert IIIII esophagogastric junction cancer and gastric cancer The second purpose is to evaluate the success rate of inserting anvil fork into esophageal lumen at first attempt attempts of inserting anvil fork into esophagus time of esophagojejunostomyrecovery course and compare the postoperative hospital stay of the patients enrolled in this study
Discussion This CLASS15-01 trial is the first prospective randomized two-arm controlled study to determine the safety and efficiency of OGT method compared with traditional overlap method Through this trial we hope to show that experienced surgeons can safely perform OGT-assisted overlap esophagojejunostomy for Siewert IIIII esophagogastric junction cancer and gastric cancer
Detailed Description:
Methods Objectives This CLASS15-01 trial is a prospective multicenter trial for OGT-assisted overlap esophagojejunostomy and traditional overlap method during totally laparoscopic total gastrectomy for Siewert IIIII esophagogastric junction cancer and gastric cancer The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of OGT method compared with traditional overlap method for Siewert IIIII esophagogastric junction cancer and gastric cancer The second purpose is to evaluate the success rate of inserting anvil fork into esophageal lumen at first attempt attempts of inserting anvil fork into esophagus time of esophagojejunostomyrecovery course and compare the postoperative hospital stay of the patients enrolled in this study
Study design This CLASS15-01 trial is a prospective multicenter randomized controlled open and non-inferiority trial comparing the safety of OGT method during TLTG for Siewert III II esophagogastric junction cancer and gastric cancer compared with traditional overlap method
Participating surgeons To participate in this CLASS15 trial the responsible surgeons should meet the following qualifications first completing at least 50 cases of TLTG with D2 lymphadenectomysecond passing the blind review of surgery video Briefly the applicants should provide the videos of TLTG with traditional overlap and OGT method in recent 3 months three cases each to the CLASS Research CouncilCLASS Research Council will select two videos of traditional overlap and OGT method separately and randomly appoint three experts to peer review blindly When three experts unanimously approved it the applicant will be permitted to participate in this study as a researcher
Sample size calculation This is a non-inferiority verification study on clinical safety with the early operative morbidity and mortality rate as the main index for safety evaluation According to the previous reports the morbidity and mortality rate for TLTG with traditional overlap is about 29 Setting α0025 β 02 and the noninferiority margin δ 5 the sample size required for each group is 148 cases Considering that the dropout rate for this clinical study is about 5 the sample size is determined as 156 cases in each group
Inclusion criteria Aged 18-80 years Primary lesion is pathologically diagnosed as gastric adenocarcinoma Expected to live more than 1 year Tumor located located in gastroesophageal junction GEJ involve esophagus no more than 2cm or in the upper upper to middle or entire stomach and intend to perform laparoscopic total gastrectomy with D2 lymphadenectomy No history of upper abdominal surgery except for laparoscopic cholecystectomy Preoperative performance status ECOG Eastern Cooperative Oncology Group of 0 or 1 Preoperative ASA American Society of Anesthesiologists scoring I-III Sufficient organ functions Written informed consent
Exclusion criteria Women during pregnancy or breast-feeding Body temperature 38 C before surgery or infectious disease with a systemic therapy indicated Severe mental disease Confirmed stage IV AJCC 8th during surgery Severe respiratory disease Severe hepatic and renal dysfunction Unstable angina pectoris or history of myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months Gastric cancer complications bleeding perforation obstruction that requiring emergency surgery
Randomized grouping In this study the central dynamic stratified randomization method is adopted and the factors including age TNM stage tumor location neoadjuvant BMI and investigators are considered After each case is enrolled the research center will arrange the research assistant to send the information of included cases ageTNM stage tumor location neoadjuvant and BMI to the data center After analyzing the case information by the center randomization department the case grouping will be determined
Quality control To ensure the rationality of the ESJ procedure a series of photographs of ESJ traditional and OGT are taken for assessment All photographs will be saved and submitted to CLASS data center within 1 week after the operation The CLASS Research Committee will monitor and review regularly to ensure the quality of operation
Outcome measurements Primary endpoint The primary endpoint of the CLASS15 trial is noninferiority in the early operative morbidity and mortality which are defined as the event observed within 30 days following surgery The postoperative complications are defined and graded according to the grading system of
Clavien-Dindo Classification To measure this endpoint the criteria are suggested in details as follows
Intraoperative complications
1 Surgery-related complications intraoperative hemorrhage 400 ml and injury
2 Pneumoperitoneum-related complications hypercapnia mediastinal emphysema subcutaneous emphysema aeroembolism and respiratory and circulatory instability caused by pneumoperitonum
3 Anesthesia-related complication
Early postoperative complications
1 Surgery-related complications wound complications infection effusion dehiscencepoor healing intra-abdominal active bleedingdigestive tract active bleeding anastomotic leakage anastomotic stenosis intestinal fistula pancreatic fistula chylous fistula intra-abdominal abscess formation gastroparesis intestinal paralysis intestinal obstruction cholecystitis pancreatitis etc
2 System-related complications pneumonia pleural effusion pulmonary embolism cardiocerebrovascular complications deep venous thrombosis urinary tract complicationscatheter-related complications condition of painetc
Secondary endpoint The secondary endpoint of this study is the time of oesophagojejunostomy the success rate of inserting anvil fork into oesophagal lumen at first attempt the number of attempts to insert anvil fork into oesophagus and postoperative recovery course which is assessed by time to first ambulation flatus liquid diet soft diet etc In addition the length of postoperative hospital stay will be recorded
Follow-up The patients in both groups will be followed up 6 months after operation A physical examination a complete blood count blood biochemical examination albumin prealbumin total bilirubin direct bilirubin AST ALT creatinine blood urea nitrogen and blood glucose and serum tumor markers AFP CEA CA19-9 CA12-5 and CA72-4 analyses will be performed In addition imageological examination total abdominal and pelvic enhanced CT chest X-ray upper gastrointestinal tract iodine imaging gastroscopy ultrasonography whole body bone scan PET-CT etc will also be performed if needed All the results will be recorded and evaluated by the specialist
Statistical analysis Statistical analysis will be performed with SPSS 250 SPSS Inc Chicago IL USA Continuous variables with normal distribution are expressed as the mean standard deviation and continuous variables with a skewed distribution are expressed as the median interquartile range IQR and were compared across groups using Continuous variables were compared across groups using the independent t-test or Mann-Whitney U test if the data were highly skewed Categorical variables are expressed as the number and percentage and were compared with the chi-square test or Fishers exact testif a variables exact theory frequency was less than 1 P 005 was considered statistically significant
Study design This CLASS15-01 trial is a prospective multicenter randomized controlled open and non-inferiority trial comparing the safety of OGT method during TLTG for Siewert III II esophagogastric junction cancer and gastric cancer compared with traditional overlap method
Participating surgeons To participate in this CLASS15 trial the responsible surgeons should meet the following qualifications first completing at least 50 cases of TLTG with D2 lymphadenectomysecond passing the blind review of surgery video Briefly the applicants should provide the videos of TLTG with traditional overlap and OGT method in recent 3 months three cases each to the CLASS Research CouncilCLASS Research Council will select two videos of traditional overlap and OGT method separately and randomly appoint three experts to peer review blindly When three experts unanimously approved it the applicant will be permitted to participate in this study as a researcher
Sample size calculation This is a non-inferiority verification study on clinical safety with the early operative morbidity and mortality rate as the main index for safety evaluation According to the previous reports the morbidity and mortality rate for TLTG with traditional overlap is about 29 Setting α0025 β 02 and the noninferiority margin δ 5 the sample size required for each group is 148 cases Considering that the dropout rate for this clinical study is about 5 the sample size is determined as 156 cases in each group
Inclusion criteria Aged 18-80 years Primary lesion is pathologically diagnosed as gastric adenocarcinoma Expected to live more than 1 year Tumor located located in gastroesophageal junction GEJ involve esophagus no more than 2cm or in the upper upper to middle or entire stomach and intend to perform laparoscopic total gastrectomy with D2 lymphadenectomy No history of upper abdominal surgery except for laparoscopic cholecystectomy Preoperative performance status ECOG Eastern Cooperative Oncology Group of 0 or 1 Preoperative ASA American Society of Anesthesiologists scoring I-III Sufficient organ functions Written informed consent
Exclusion criteria Women during pregnancy or breast-feeding Body temperature 38 C before surgery or infectious disease with a systemic therapy indicated Severe mental disease Confirmed stage IV AJCC 8th during surgery Severe respiratory disease Severe hepatic and renal dysfunction Unstable angina pectoris or history of myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months Gastric cancer complications bleeding perforation obstruction that requiring emergency surgery
Randomized grouping In this study the central dynamic stratified randomization method is adopted and the factors including age TNM stage tumor location neoadjuvant BMI and investigators are considered After each case is enrolled the research center will arrange the research assistant to send the information of included cases ageTNM stage tumor location neoadjuvant and BMI to the data center After analyzing the case information by the center randomization department the case grouping will be determined
Quality control To ensure the rationality of the ESJ procedure a series of photographs of ESJ traditional and OGT are taken for assessment All photographs will be saved and submitted to CLASS data center within 1 week after the operation The CLASS Research Committee will monitor and review regularly to ensure the quality of operation
Outcome measurements Primary endpoint The primary endpoint of the CLASS15 trial is noninferiority in the early operative morbidity and mortality which are defined as the event observed within 30 days following surgery The postoperative complications are defined and graded according to the grading system of
Clavien-Dindo Classification To measure this endpoint the criteria are suggested in details as follows
Intraoperative complications
1 Surgery-related complications intraoperative hemorrhage 400 ml and injury
2 Pneumoperitoneum-related complications hypercapnia mediastinal emphysema subcutaneous emphysema aeroembolism and respiratory and circulatory instability caused by pneumoperitonum
3 Anesthesia-related complication
Early postoperative complications
1 Surgery-related complications wound complications infection effusion dehiscencepoor healing intra-abdominal active bleedingdigestive tract active bleeding anastomotic leakage anastomotic stenosis intestinal fistula pancreatic fistula chylous fistula intra-abdominal abscess formation gastroparesis intestinal paralysis intestinal obstruction cholecystitis pancreatitis etc
2 System-related complications pneumonia pleural effusion pulmonary embolism cardiocerebrovascular complications deep venous thrombosis urinary tract complicationscatheter-related complications condition of painetc
Secondary endpoint The secondary endpoint of this study is the time of oesophagojejunostomy the success rate of inserting anvil fork into oesophagal lumen at first attempt the number of attempts to insert anvil fork into oesophagus and postoperative recovery course which is assessed by time to first ambulation flatus liquid diet soft diet etc In addition the length of postoperative hospital stay will be recorded
Follow-up The patients in both groups will be followed up 6 months after operation A physical examination a complete blood count blood biochemical examination albumin prealbumin total bilirubin direct bilirubin AST ALT creatinine blood urea nitrogen and blood glucose and serum tumor markers AFP CEA CA19-9 CA12-5 and CA72-4 analyses will be performed In addition imageological examination total abdominal and pelvic enhanced CT chest X-ray upper gastrointestinal tract iodine imaging gastroscopy ultrasonography whole body bone scan PET-CT etc will also be performed if needed All the results will be recorded and evaluated by the specialist
Statistical analysis Statistical analysis will be performed with SPSS 250 SPSS Inc Chicago IL USA Continuous variables with normal distribution are expressed as the mean standard deviation and continuous variables with a skewed distribution are expressed as the median interquartile range IQR and were compared across groups using Continuous variables were compared across groups using the independent t-test or Mann-Whitney U test if the data were highly skewed Categorical variables are expressed as the number and percentage and were compared with the chi-square test or Fishers exact testif a variables exact theory frequency was less than 1 P 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None