scholarly journals Recanalization in Uncut Roux-en-Y Reconstruction: An Animal Experiment and a Clinical Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Feng Wu ◽  
Zhizhan Ni ◽  
Hongliang Diao ◽  
Chenshen Huang ◽  
Song Wang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Study ◽  
Animal Experiment ◽  
Distal Gastrectomy ◽  
Bile Reflux ◽  
Primary Study ◽  
Afferent Limb ◽  
Miniature Pigs ◽  
Number Of Patients

Background: Because of the challenge of jejunal closure recanalization, uncut Roux-en-Y reconstruction remains controversial. This study aimed to investigate the incidence of recanalization after uncut Roux-en-Y reconstruction in pigs and a small number of patients.Methods: Twenty miniature pigs were subjected to distal gastrectomy and uncut Roux-en-Y reconstruction using various rows of linear staplers to block the intestine. The pigs were sacrificed, and the incidence of recanalization was investigated 1 month after the operation. From December 2018 to June 2019, 10 patients with gastric cancer who had undergone elective laparoscopy-assisted distal gastrectomy and uncut Roux-en-Y reconstruction were included in this study. The primary study outcome was recanalization of the afferent limb, demonstrated by gastrointestinal radiography 1, 3, and 6 months after surgery. Various numbers of staple lines across the afferent jejunal limb were applied for closure: 2 staple lines in 2 pigs, 4 staple lines in 6 pigs, 6 staple lines in 8 pigs, and 8 staple lines in 4 pigs.Results: Complete recanalization was detected in all 20 pigs 1 month postoperatively. Recanalization was detected in five cases (50%) by gastrointestinal radiography. Among them, 1 case of recanalization was found in the 1st month after the operation, 2 cases were found in the 3rd month, and another 2 cases were found in the 6th month. Bile reflux was detected by endoscopy in 2 patients with recanalization.Conclusions: The occurrence of afferent limb recanalization after uncut Roux-en-Y reconstruction is high, and using additional staplers alone cannot decrease the incidence of recanalization. Based on our study, uncut Roux-en-Y reconstruction is not recommended.

Randomized phase III trial of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer (JCOG0912).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4020-4020 ◽  
Author(s):  
Hitoshi Katai ◽  
Junki Mizusawa ◽  
Hiroshi Katayama ◽  
Shinji Morita ◽  
Takanobu Yamada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Primary Endpoint ◽  
Treatment Guidelines ◽  
Distal Gastrectomy ◽  
Clinical Stage ◽  
Stage I ◽  
Phase Iii ◽  
Open Distal Gastrectomy ◽  
Number Of Patients ◽  
Nodal Dissection

4020 Background: The number of patients undergoing laparoscopy-assisted distal gastrectomy (LADG) has been increasing worldwide. Several retrospective studies have demonstrated equivalent survival after LADG compared to open distal gastrectomy (ODG). However, no confirmatory randomized controlled trials has been published in a peer review journal to evaluate the efficacy of LADG compared with ODG, ensuring strict surgical skill and quality control of surgery. We conducted phase III study to confirm that LADG is not inferior to ODG in efficacy. Methods: Eligibility criteria included histologically proven adenocarcinoma in the middle or lower third of the stomach; clinical stage I tumor (T1N0, T1N1, T2(MP)N0). Patients were preoperatively randomized to ODG or LADG. LADG was performed by accredited surgeon. The extent of nodal dissection was decided according to Japanese gastric cancer treatment guidelines. The primary endpoint is relapse-free survival (RFS) and the secondary endpoints are overall survival (OS), short-term clinical outcomes, and postoperative quality of life. Planned sample size was 920 patients in total, which was determined with at least 80% power, a one-sided alpha of 5%, and a non-inferiority margin for a hazard ratio of 1.54. Before the 1st interim analysis, the primary endpoint was amended from OS to RFS in 2015 because the surrogacy of RFS for OS was demonstrated and the predicted number of events for OS was smaller than expected. Results: A total of 921 patients were randomized (ODG 459, LADG 462) between Mar. 2010 and Nov. 2013. Among 921 patients, 912 patients (99%) underwent assigned surgery. Conversion to ODG was needed for 16 patients (3.5%) in LADG arm mainly due to advanced disease. 5-year RFS was 94.0% (95% CI: 91.4-95.9%) in ODG and 95.1% (92.7-96.8%) in LADG. LADG was non-inferior to ODG for RFS. (HR: 0.84 [90% CI: 0.56-1.27 ( < 1.54)], p for non-inferiority = 0.008). 5-year OS was 95.2% (92.7-96.8) in ODG and 97.0% (94.9-98.2) in LADG (HR: 0.83 [95% CI: 0.49-1.40]). Conclusions: The non-inferiority of LADG to ODG in RFS was confirmed. LADG has been established as one of the standard treatments for clinical stage I gastric cancer. Clinical trial information: UMIN000003319.

Clinical Study of Surgical Cases of Gastric Cancer in Hokkaido.

1992 ◽  
Vol 40 (5) ◽  
pp. 1019-1029
Author(s):  
Hajime MIYAUCHI ◽  
Norimitsu HASEGAWA ◽  
Tsunemi HIGASHI ◽  
Yoshio MURASHIMA ◽  
Toshihiro SUGA ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Study

Evaluation of Hand-Assisted Laparoscopic Distal Gastrectomy for Patients with Early Gastric Cancer

2003 ◽  
Vol 52 (4) ◽  
pp. 717-725
Author(s):  
Yoshibumi NIITSUMA ◽  
Tsuneo KAWASAKI ◽  
Hajime TSUKUI ◽  
Yoshinobu TAKAHASHI ◽  
Masamitsu MAEDA ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Early Gastric Cancer ◽  
Distal Gastrectomy ◽  
Laparoscopic Distal Gastrectomy

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

The most frequently asked question to a statistician: The sample size

2017 ◽  
Vol 23 (5) ◽  
pp. 644-646 ◽  
Author(s):  
Maria Pia Sormani
Keyword(s):  
Clinical Study ◽  
Sample Size ◽  
Study Design ◽  
Treatment Effect ◽  
Sample Size Calculation ◽  
Ethical Implications ◽  
Number Of Patients ◽  
Reducing Costs ◽  
Correct Size

The calculation of the sample size needed for a clinical study is the challenge most frequently put to statisticians, and it is one of the most relevant issues in the study design. The correct size of the study sample optimizes the number of patients needed to get the result, that is, to detect the minimum treatment effect that is clinically relevant. Minimizing the sample size of a study has the advantage of reducing costs, enhancing feasibility, and also has ethical implications. In this brief report, I will explore the main concepts on which the sample size calculation is based.

scholarly journals Impact of the Number of Dissected Lymph Nodes on Survival for Gastric Cancer after Distal Subtotal Gastrectomy

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Chang-Ming Huang ◽  
Jian-Xian Lin ◽  
Chao-Hui Zheng ◽  
Ping Li ◽  
Jian-Wei Xie ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Lymph Nodes ◽  
Distal Gastrectomy ◽  
Stage I ◽  
Stage Ii ◽  
Stage Iii ◽  
Prognostic Impact ◽  
Term Survival

Objectives. To investigate the prognostic impact of the number of dissected lymph nodes (LNs) in gastric cancer after curative distal gastrectomy.Methods. The survival of 634 patients who underwent curative distal gastrectomy from 1995 to 2004 was retrieved. Long-term surgical outcomes and associations between the number of dissected LNs and the 5-year survival rate were investigated.Results. The number of dissected LNs was one of the most important prognostic indicators. Among patients with comparable T category, the larger the number of dissected LNs was, the better the survival would be (). The linear regression showed that a significant survival improvement based on increasing retrieved LNs for stage II, III and IV (). A cut-point analysis yields the greatest variance of survival rate difference at the levels of 15 LNs (stage I), 25 LNs (stage II) and 30 LNs (stage III).Conclusion. The number of dissected LNs is an independent prognostic factor for gastric cancer. To improve the long-term survival of patients with gastric cancer, removing at least 15 LNs for stage I, 25 LNs for stage II, and 30 LNs for stage III patients during curative distal gastrectomy is recommended.

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