1.Phase III multi-centre open-label randomized controlled trial of selective internal radiation therapy (SIRT) versus Sorafenib in locally advanced hepatocellular carcinoma(SIRveNIB)
Ariunaa Kh ; Sanduijav R ; Bolormaa Ya ; Tuyatsetseg A
Mongolian Medical Sciences 2016;177(3):20-24
Background
This study is a multi-centre, open-label, randomised controlled trial that will compare the impact of
selective internal radiation therapy (SIRT) using SIR-Spheres® yttrium-90 microspheres versus sorafenib
on overall survival in patients with locally advanced hepatocellular carcinoma (HCC). A definitive RCT
comparing the 2 most promising therapies in locally-advanced HCC will impact on outcomes in a large
number of patients and change clinical practice. This will also pave the way for future trials in combined
modality therapies in HCC.
Methods
The study is structured so that patients with locally advanced HCC, who satisfy the study eligibility
criteria, will be randomised to receive either: Treatment Arm A: Oral Sorafenib therapy at a dose of 400
mg b.i.d until disease progression, no further response, complete regression or unacceptable toxicity or
Treatment Arm B: A single administration of SIR-Spheres into the liver targeted at HCC in the liver by
the trans-arterial route.
Results
Twenty patients treated with 90Y-RE and nineteen patients received Sorafenib at our institution from 14
March 2011, and 30 June 2016 were included. Data from 39 consecutive patients were analyzed. The
majority of patients were Child Pugh class B(90%), Barcelona Clinic liver Cancer(BCLC) stage C(58.5%)
and Okuda class I (89.5%). Approximately 71% patients diagnosed in IIIa stage and 70% of patients had
HBV infection. In the analysis for best response, three of 20 patients in the SIRT group (15%) achieved
a partial response 7 of 19 patients (46%) had stable disease, whereas in Sorafenib group, two of 19
patients in the SIRT group (12%) achieved a partial response 9 of 19 patients (39%) had stable disease.
Conclusion
This study shows the potential efficacy of SIR-Spheres and sorafenib. In summary, selective internal
radiation therapy (SIRT) using SIR-Spheres is a promising treatment for well selected patients with
unresectable HCC. Sorafenib is effective for the patients with locally advanced HCC without portal vein
thrombosis (PVT).
2. WHIPPLE’S PANCREATICODUODENECTOMY: OUTCOMES AT THE NATIONAL CANCER CENTER MONGOLIA BETWEEN 2008-2016
Taivanbaatar E ; Sanduijav R ; Chinburen J
Journal of Surgery 2016;20(2):72-77
Introduction: In 1899, William S.Halsted of The Johns Hopkins Hospitaldescribed a transduodenal local ampullaryresection with reanastomosis of thepancreatic and bile ducts to the duodenumin a patient presenting with obstructivejaundice.During the 1940s and 1950s,pancreaticoduodenectomy was performedin limited numbers with variable results. Atthat time, the operation carried a hospitalmortality that approached 25% in someseries, leading some authorities to abandonthe procedure. In the last several decades,improved hospital morbidity, mortality, andsurvival after pancreaticoduodenectomy havebeen reported. Many centers now reportoperative mortalities of less than 4% [1].Pancreatic adenocarcinoma is the 4th leadingcause of cancer death in the United States.The National Cancer Institute estimated thatthere were 43,140 new cases of pancreaticcancer in the United States in 2010 andthat pancreatic cancer was responsible for36,800 deaths [2].In Mongolia pancreaticcancer is uncommon disease and pancreaticadenocarcinomas incidence in Mongolia100’000 : 2,4; therefore 85% cases arediagnosed in unresectable stage [3].Materials and methods: Weretrospectively reviewed and calculated withstata13.0for patients(n96) who underwentresections (PD by Whipple operation) ofperiampullary (pancreatic, CBD and ampullaeVater) tumorsin HPBSD of Cancer CenterMongolia between 2008-2016.Results: This was retrospective chartreview of 96 patients treated withinthe Hepato Pancreatico Biliary SurgeryDepartment of Cancer Center Mongolia from2008 to 2016. Patient demographics andrelevant patient history including age, sex,date of birth, race, and co-morbidities weredocumented. Inpatient variables included thedate of procedure, complications, lengthof stay in the intensive care unit (ICU) andhospital, and disposition after discharge.At the time of the study total number ofHPBSD operations were 2963, thereforeall pancreatic and periampullary operations251(8,4%), Whipple operation 96 (3,2%)wasperformed. The operative and perioperativecharacteristics for patients who underwentpancreaticoduodenectomy n96(38.2%for all pancreatic and periampullaryoperations n251), 2008-n3(3,1%),2009- n7(7.2%), 2010-n13(13.5%);2011-n16(6.2%);2012-n10(10.2%);2013-n112(12.5%);2014-n19(19.8%);2015-n13(13.5%);2016-n13(13.5%); were meanage 54, sex ratio/m:f/ n47(49%):n49(51%),mean hospital stay 20, mean operationtime 434.5min, mean operative blood loss333ml. In the histological review werepancreatic adenocarcinoma 60%, ampullaeVater adenocarcinoma 20%, common bileduct adenocarcinoma 4.3%, benign or insitu tumours (IPMN, pancreatic adenoma,cystadenoma, and Frantz tumor(SPN) etc.)14%. The perioperative mortality(definedas death in hospital or within 30 daysof discharge) for patients undergoingpancreaticoduodenectomy wasn=6(6,2%)and perioperative morbidity or complicationrate was n=39(40,6%). At the time of ourstudy period complications were occurredwith DGE n4(4,1%) bleeding n3(3.1%),abdominal abscess n1(1%), gastric fistulen1(1%), stenosis of gastric anastomosisn1(1%), hypoglycemic coma n1(1%),pancreatic fistule n14(14,6%), perforation ofsmall intestine n1(1%), pneumonia n1(1%),ascites n1(1%) and post-op complicationsneeded secondary procedures : relaparotomyn=12(12,5%) .Only wound infection werethe most frequent complication15(15,6%) .Conclusion: Since 2009, in CancerCenter Mongolia, we are using new methodthat “mucosa to duct” modification forpancreatojejunostomy with protectionby decompress drain in Wirsung duct forpancreaticoduodenectomy is very beneficialmethod to decrease pancreatic fistulecomplication rate and it was a big stepto develop of pancreatic surgery field inMongolia. The our mean hospital stay(20days) after Whipple operation is not toolong with compare other countries (23-27)[2]. Until now, in Mongolia doesn’t have anycomplete studies about results of surgicaltreatment for pancreatic cancer and ourstudy needs completion, to improve and tocontinue.
3.Effect Of Moxa At Guanyuan Acupoint On Qlq Of Chemotherapy Patients And Cx43 Expression Of The Cyclophosphamide Treated Mice Stomach
Enkhtuya V ; Sanduijav R ; Chai Tie Qu
Journal of Oriental Medicine 2012;3(2):22-22
Objective: To explore effects of using direct moxa at Guanyuan
acupoint in palliative care for cancer patients during the
chemotherapy
Methods: In single blind, randomized controlled clinical trial,
examined effects of using direct moxa at Guanyuan acupoint. 24
gastric cancer patients undergoing postoperative chemotherapy at
National Cancer Center of Mongolia were recruited and randomized
into 2 groups: control and intervention. The intervention consisted of
25 min direct moxa at Guanyuan acupoint once a day for 5 days.
The EORTC QoL 30 questionnaires were filled by the patients and
self-designed patient assessment questionnaire based on MD
Anderson Symptom Inventory were filled by blinded medical
personal, before and after the chemotherapy. Study was approved
by Ethical Committee of MOH of Mongolia.
Explored the relationship between moxa at Guanyuan acupoint and
Connexin 43 (Cx43) expression in the cyclophosphamide treated
mice stomach by IHC method.
Results: The QoL of post-operative gastric cancer patients before
chemotherapy were similar to EORTC reference value.
Chemotherapy will significantly decrease patients QoL especially
nausea & vomiting, appetite loss symptom scales. Moxa at
Guanyuan had significantly decreased fatigue score of the post-
operative chemotherapy gastric cancer patients (P<0.05) and
positively regulated Global Health score and other symptom scales
especially nausea & vomiting, appetite loss scores. During the
treatment no adverse effects of moxa treatment were observed.
IHC analysis of cyclophosphamide treated mice stomach reveals
Strong connexin 43 expresion in gastric crypt. Conclusion:
Guanyuan (CV 4) is Front-Mu Point of the Small Intestine, a
crossing point of Three Yin Meridians of Foot, Stomach meridian of
Foot Yang Ming and Conception Vessel. It is the one acupoint can
gather qi of many meridians, which has Yin within the yang
character and considered the physical center of gravity of the human
body and seat of one\'s internal energy. Therefore it could warm the
kidney to invigorate yang, tonify the Yuan- Primary qi, regulate
Thoroughfare and Conception Vessels, thus can cultivate yuan-
primary energy. Moxa is the non invasive treatment method of
acupuncture and moxa at Guanyuan can be broadly used in cancer
palliative care to reduce the side effects of chemotherapy and
improve quality of life of cancer patients.