Table 4. Clinical findings of interventional clinical trials involving gastrectomy for GC.
| Authors | Year | Trial | NCTID | Number enrolled |
Inclusion criteria | Primary outcome |
Result |
|---|---|---|---|---|---|---|---|
| Sakuramoto et al [30] | 2007 | Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine | NCT00152217 | 529 | LAGC | Overall survival | Oral fluoropyrimidine is an effective adjuvant treatment for LAGC |
| Nakajima et al [31] | 2007 | Randomized controlled trial of adjuvant uracil-tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer | NCT00152243 | 190 | Seronegative, node positive GC | Overall survival | Significant survival benefit for postoperative adjuvant chemotherapy with uracil-tegafur |
| Sasako et al [32] | 2008 | D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer | NCT00149279 | 523 | GC | Overall survival | Treatment with D2 lymphadenectomy plus para-aortic nodal dissection does not improve the survival rate |
| Iwahashi et al [27] | 2009 | Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial | NCT00746161 | 44 | GC | Quality of life | No difference between double tract and Roux-En-Y for total gastrectomy |
| Miyashiro et al [33] | 2011 | Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2 | NCT00147147 | 268 | GC | Overall survival | No benefit in overall and relapse-free survival with intraperitoneal cisplatin, postoperative intravenous cisplatin and 5-FU |
| Kim et al [26] | 2013 | Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301) | NCT00546468 | 164 | Early distal GC | 5-year DFS | No difference in long-term benefits between laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) |
| Lee et al [34] | 2013 | Morbidity and mortality after laparoscopic gastrectomy for advanced gastric cancer: results of a phase II clinical trial | NCT01441336 | 204 | LAGC | Feasibility of laparoscopic gastrectomy | LG with D2 lymphadenectomy is safe and feasible |
| Bernini et al [35] | 2013 | The Cholegas Study: safety of prophylactic cholecystectomy during gastrectomy for cancer: preliminary results of a multicentric randomized clinical trial | NCT00757640 | 172 | GC | Evaluation of the incidence of cholelithiasis postoperatively | Concomitant cholecystectomy adds no extra perioperative morbidity, mortality and costs |
| Haverkamp et al [5] | 2015 | Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial) | NCT02248519 | 210 | Surgically resectable GC | Postoperative hospital stay | Laparoscopic surgery provides shorter hospital stay |
| Abdikarim et al [36] | 2015 | Enhanced recovery after surgery with laparoscopic radical gastrectomy for stomach carcinomas | NCT01955096 | 61 | GC | Postoperative hospital stay | ERAS programme is associated with shorter hospital stay |
| Nakamura et al [37] | 2016 | Randomized clinical trial comparing long-term quality of life for Billroth I versus Roux-en-Y reconstruction after distal gastrectomy for gastric cancer | NCT01065688 | 122 | GC | Quality of life | No difference between Billroth I and Roux-en-Y reconstruction |
| Oh et al [38] | 2017 | Ultrasonically Activated Shears Reduce Blood Loss without Increasing Inflammatory Reactions in Open Distal Gastrectomy for Cancer: A Randomized Controlled Study | NCT01971775 | 56 | GC | Estimated blood loss (EBL) during surgery | UAS reduced EBL without increasing inflammatory reactions |
| Lee et al [39] | 2017 | Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial | NCT02347956 | 40 | Early GC | 30-day morbidity and mortality | Reduced-port robotic distal gastrectomy could be a valid alternative to conventional robot distal gastrectomy |
| Park et al [40] | 2018 | Laparoscopy-Assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001) | NCT01088204 | 204 | LAGC | Noncompliance rate of lymph node dissection | LDG is feasible for D2 lymph node dissection |
| Kang et al [41] | 2018 | Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial | NCT01938313 | 97 | GC | Recovery time | ERAS is safe and enhances postoperative recovery after total laparoscopic distal gastrectomy in GC |
| Zheng et al [42] | 2018 | Comparison of 3D laparoscopic gastrectomy with a 2D procedure for gastric cancer: A phase 3 randomized controlled trial | NCT02327481 | 438 | GC | Short-term postoperative complications and mortality | 3D laparoscopic gastrectomy does not shorten the operation time compared with 2D laparoscopic gastrectomy, but provides less intraoperative blood loss and a lesser occurrence of excessive bleeding |
| Li et al [43] | 2019 | Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial | NCT02404753 | 96 | LAGC receiving neoadjuvant therapy | 3-year recurrence free survival | LDG provides better outcomes than the ODG approach |
| Ahn et al [44] | 2019 | Long-term Survival Outcomes of Laparoscopic Gastrectomy for Advanced Gastric Cancer: Five-year Results of a Phase II Prospective Clinical Trial | NCT01441336 | 157 | LAGC | 3-year recurrence free survival | Laparoscopic gastrectomy with D2 lymphadenectomy shows acceptable 3-year DFS |
| Yu et al [45] | 2019 | Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial | NCT01609309 | 1056 | LAGC | 3-year recurrence free survival | LDG is not significantly superior to ODG |
| Kim et al [46] | 2019 | Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer: The KLASS-01 Randomized Clinical Trial | NCT00452751 | 1416 | Stage I GC | 5-year DFS | LDG is a safe alternative to ODG for stage I GC |
| Guo et al [47] | 2019 | Combined Surgery and Extensive Intraoperative Peritoneal Lavage vs Surgery Alone for Treatment of Locally Advanced Gastric Cancer: The SEIPLUS Randomized Clinical Trial | NCT02745509 | 662 | LAGC | Short-term postoperative complications and mortality | Patients with LAGC appear to be candidates for the extensive intraoperative peritoneal lavage approach |
| Wang et al [48] | 2019 | Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial | NCT02464215 | 446 | LAGC | Morbidity and mortality within 30 postoperative days | LDG was safe and feasible compared with conventional ODG |
| Chen et al [49] | 2020 | Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial | NCT03050879 | 266 | Potentially resectable GC | Number of retrieved lymph nodes | Indocyanine green improve the number of lymph node dissections and reduce lymph node noncompliance without increased complications |