- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02845986
Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer (CLASS-04)
Safety and Feasibility of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Locally Advanced Upper Third Gastric Cancer: A Multicenter Phase II Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Radical resection is still the primary method of treating advanced gastric cancer.According to the Japanese treatment guidelines for gastric cancer, D2 lymphadenectomy, including No. 10 lymph node dissection, should be adopted for upper third gastric carcinoma.The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.
In the early, splenectomy was performed to remove No. 10 lymph node. With the improvement of medical knowledge and surgical technique, spleen-preserving No. 10 lymph node dissection has been recognized by more and more surgeons. However, due to the special and complex anatomy of the spleen, spleen-preserving No. 10 lymph node dissection is difficult, even in open surgery; consequently, the surgery cannot be performed in many centers.
Laparoscopic surgery has distinct minimally invasive advantages, such as small incisions, less blood loss, less postoperative pain, mild postoperative inflammatory reactions, a quick recovery of gastrointestinal function, shorter hospital stays and obvious cosmetic effects. Since Kitano et al. first reported laparoscopic gastrectomy for gastric cancer in 1994, laparoscopic techniques have developed rapidly. The techniques are becoming increasingly mature, making it possible to perform laparoscopic spleen-preserving No. 10 lymph node dissection. Our center first proposed "Huang's three-step maneuver", a new operative method suitable for laparoscopic spleen-preserving No. 10 lymph node dissection. This method simplifies the procedure of laparoscopic spleen-preserving No. 10 lymph node dissection and facilitates its popularization and promotion.
However, it remains a controversial international issue if it is safe and feasible to routinely conduct laparoscopic spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer.A number of retrospective studies have successively confirmed the safety, feasibility and oncological efficacy of laparoscopic spleen-preserving No. 10 lymph node dissection.But there is no multicenter prospective studies to identify the results.
Therefore, The study is through a prospective, multicenter, open, single-arm, non-inferiority study,to explore the safety and feasibility of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma(cT2-4a, N-/+, M0).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Beijing
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Haidian, Beijing, China, 100142
- Beijing Cancer Hospital
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Chongqing
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Shapingba, Chongqing, China, 400038
- Southwest Hospital
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Fujian
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Fuzhou, Fujian, China, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, China, 350001
- Fujian Provincial Hospital
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Longyan, Fujian, China, 364000
- Longyan First Hospital
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Putian, Fujian, China, 351100
- The First Hospital of Putian City
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Xiamen, Fujian, China, 361003
- The First Affiliated Hospital of Xiamen University
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Zhangzhou, Fujian, China, 363000
- Zhangzhou Municipal Hospital of Fujian Province
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Guangdong Provincial Hospital of Traditional Chinese Medicine
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Guangzhou, Guangdong, China, 510080
- Guangdong General Hospital
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Guangzhou, Guangdong, China, 510515
- Nanfang Hospital of Southern Medical University
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Meizhou, Guangdong, China, 514031
- Meizhou People's Hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital
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Jilin
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Changchun, Jilin, China, 130041
- The Second Hospital of Jilin University
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Qinghai
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Xining, Qinghai, China, 810001
- Qinghai University Affiliated Hospital
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Shanghai
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Pudong, Shanghai, China, 200135
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
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Xuhui, Shanghai, China, 200032
- Shanghai Zhongshan Hospital
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Shanxi
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Xi'an, Shanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Xinjiang
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Xinjiang, Xinjiang, China, 830054
- The first affiliated hospital of Xinjiang medical university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 to 75 years old
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- Locally advanced tumor in the upper third stomach(cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition)
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Exclusion Criteria:
- Pregnant and lactating women
- Suffering from severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node (diameter over 3cm)supported by preoperative imaging including enlarged or bulky No.10 lymph node
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: No.10 lymph node dissections
Patients with locally advanced upper third gastric carcinoma will performed laparoscopic spleen-preserving No.10 lymph node dissections.After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy.
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After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al.
Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma.
oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall postoperative morbidity rates
Time Frame: 30 days
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Refers to the incidence of early postoperative complications.
The early postoperative complication are defined as the event observed within 30 days after surgery.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year recurrence pattern
Time Frame: 36 months
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Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
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36 months
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The variation of weight
Time Frame: 3, 6, 9 and 12 months
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The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
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3, 6, 9 and 12 months
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The variation of cholesterol
Time Frame: 3, 6, 9 and 12 months
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The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
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3, 6, 9 and 12 months
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The variation of album
Time Frame: 3, 6, 9 and 12 months
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The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
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3, 6, 9 and 12 months
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The variation of body temperature
Time Frame: 8 days
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The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
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8 days
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The variation of white blood cell count
Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
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The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
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Preoperative 3 days and postoperative 1, 3, and 5 days
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The variation of hemoglobin
Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
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The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
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Preoperative 3 days and postoperative 1, 3, and 5 days
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The variation of C-reactive protein
Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
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The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
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Preoperative 3 days and postoperative 1, 3, and 5 days
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The variation of prealbumin
Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
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The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
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Preoperative 3 days and postoperative 1, 3, and 5 days
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3-year disease free survival rate
Time Frame: 36 months
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36 months
|
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Time to first ambulation
Time Frame: 30 days
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Time to first ambulation in hours is used to assess the postoperative recovery course.
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30 days
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Time to first flatus
Time Frame: 30 days
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Time to first flatus in days is used to assess the postoperative recovery course.
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30 days
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Time to first liquid diet
Time Frame: 30 days
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Time to first liquid diet in days is used to assess the postoperative recovery course.
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30 days
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Time to first soft diet
Time Frame: 30 days
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Time to first soft diet in days is used to assess the postoperative recovery course.
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30 days
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Duration of postoperative hospital stay
Time Frame: 30 days
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Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
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30 days
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3-year overall survival rate
Time Frame: 36 months
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36 months
|
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Postoperative pain
Time Frame: 30 days
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Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
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30 days
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The results of endoscopy
Time Frame: 3 and 12 months
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The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
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3 and 12 months
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Numbers of No.10 lymph node dissection
Time Frame: 9 days
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Numbers of dissected No.10 lymph nodes
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9 days
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Rates of positive No.10 lymph node
Time Frame: 9 days
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The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes).
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9 days
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Rates of splenectomy
Time Frame: 1 days
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The Rates of splenectomy are defined as the incidence of splenectomy within operation.
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1 days
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Intraoperative morbidity rates
Time Frame: 1 days
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The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
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1 days
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
- Monig SP, Collet PH, Baldus SE, Schmackpfeffer K, Schroder W, Thiele J, Dienes HP, Holscher AH. Splenectomy in proximal gastric cancer: frequency of lymph node metastasis to the splenic hilus. J Surg Oncol. 2001 Feb;76(2):89-92. doi: 10.1002/1096-9098(200102)76:23.0.co;2-i.
- Chikara K, Hiroshi S, Masato N, Goro M, Yuichi O, Hidetaka O, Hirotoshi A. Association of the number of metastatic perigastric lymph nodes with long-term survival in gastric cancer. Hepatogastroenterology. 2005 Jan-Feb;52(61):277-80.
- Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.
- Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. Erratum In: Surg Laparosc Endosc. 2013 Oct;23(5):480.
- Hyung WJ, Lim JS, Song J, Choi SH, Noh SH. Laparoscopic spleen-preserving splenic hilar lymph node dissection during total gastrectomy for gastric cancer. J Am Coll Surg. 2008 Aug;207(2):e6-11. doi: 10.1016/j.jamcollsurg.2008.04.027. No abstract available.
- Okabe H, Obama K, Kan T, Tanaka E, Itami A, Sakai Y. Medial approach for laparoscopic total gastrectomy with splenic lymph node dissection. J Am Coll Surg. 2010 Jul;211(1):e1-6. doi: 10.1016/j.jamcollsurg.2010.04.006. No abstract available.
- Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927.
- Schwarz RE. Spleen-preserving splenic hilar lymphadenectomy at the time of gastrectomy for cancer: technical feasibility and early results. J Surg Oncol. 2002 Jan;79(1):73-6. doi: 10.1002/jso.10036. No abstract available.
- Tanimura S, Higashino M, Fukunaga Y, Kishida S, Ogata A, Fujiwara Y, Osugi H. Laparoscopic gastrectomy with regional lymph node dissection for upper gastric cancer. Br J Surg. 2007 Feb;94(2):204-7. doi: 10.1002/bjs.5542.
- Huang CM, Chen QY, Lin JX, Zheng CH, Li P, Xie JW. Huang's three-step maneuver for laparoscopic spleen-preserving No. 10 lymph node dissection for advanced proximal gastric cancer. Chin J Cancer Res. 2014 Apr;26(2):208-10. doi: 10.3978/j.issn.1000-9604.2014.04.05.
- Jung MR, Park YK, Seon JW, Kim KY, Cheong O, Ryu SY. Definition and classification of complications of gastrectomy for gastric cancer based on the accordion severity grading system. World J Surg. 2012 Oct;36(10):2400-11. doi: 10.1007/s00268-012-1693-y.
- Orsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8.
- Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
- Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
- Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.
- Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57. doi: 10.7326/0003-4819-135-10-200111200-00005.
- Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.
- Dong K, Yu XJ, Li B, Wen EG, Xiong W, Guan QL. Advances in mechanisms of postsurgical gastroparesis syndrome and its diagnosis and treatment. Chin J Dig Dis. 2006;7(2):76-82. doi: 10.1111/j.1443-9573.2006.00255.x.
- Kaas R, Rustman LD, Zoetmulder FA. Chylous ascites after oncological abdominal surgery: incidence and treatment. Eur J Surg Oncol. 2001 Mar;27(2):187-9. doi: 10.1053/ejso.2000.1088.
- Assumpcao L, Cameron JL, Wolfgang CL, Edil B, Choti MA, Herman JM, Geschwind JF, Hong K, Georgiades C, Schulick RD, Pawlik TM. Incidence and management of chyle leaks following pancreatic resection: a high volume single-center institutional experience. J Gastrointest Surg. 2008 Nov;12(11):1915-23. doi: 10.1007/s11605-008-0619-3. Epub 2008 Aug 7.
- Greenblatt DY, Kelly KJ, Rajamanickam V, Wan Y, Hanson T, Rettammel R, Winslow ER, Cho CS, Weber SM. Preoperative factors predict perioperative morbidity and mortality after pancreaticoduodenectomy. Ann Surg Oncol. 2011 Aug;18(8):2126-35. doi: 10.1245/s10434-011-1594-6. Epub 2011 Feb 20.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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