Analysis of the CONKO-001 trial: Is the validity of the study sufficient to recommend adjuvant chemotherapy for pancreatic cancer?

Author(s):  
Katrin Bauer ◽  
Doris Henne-Bruns ◽  
Giulia Manzini

BACKGROUND: Since randomized controlled trials have indicated that adjuvant chemotherapy prolongs survival and reduces recurrence rates after surgical resection of pancreatic adenocarcinoma, a gemcitabine based chemotherapy has become part of the interdisciplinary treatment concept for pancreatic cancer in accordance to current guidelines. OBJECTIVES: The aim of this project was to analyse the validity of the CONKO −001 trial as a basis for the recommendation of adjuvant chemotherapy in many international guidelines. METHODS: We analysed the validity of the CONKO - 001 trial regarding study design, recruitment period, participating institutions, patient selection, randomisation, stratification, standardization of surgical treatment and histological examination, statistical methods and interpretation of results. We additionally analysed the study regarding the risk of bias using the RoB 2 Tool. Finally we reviewed the influence of the pharmaceutical industry and potential conflicts of interest. RESULTS: We identified several shortcomings of the study concerning the study protocol, the participating clinics, the patient recruitment, the randomization pattern, the standardization of surgical treatment and histological examination, the statistical methods, the evaluation of the results and the influence of the pharmaceutical industry. According to the Cochrane RoB 2 Tool the study was judged to raise some concerns in three of the five risk domains for the outcome “overall survival”. CONCLUSIONS: Based on our review, the results of the CONKO-001-study should be revisited and critically reviewed. The recommendation to include adjuvant chemotherapy with gemcitabine deserves a critical appraisal.

2019 ◽  
Vol 98 (4) ◽  
pp. 178-180

Cavernous hemangiomas are benign tumours of mesodermal origin. Even though various localizations of hemangioma have been described in the literature, its occurrence in the greater omentum is very rare. Only symptomatic hemangiomas are indicated for surgical treatment. There are case reports presenting resection or surgical removal of the greater omentum with hemangioma because of mechanical syndrome, consumption coagulopathy, bleeding, infection or suspicion of a malignancy. This article presents a case report of a patient operated on for a suspicion of carcinomatosis of the greater omentum. Histological examination found hemangiomatosis in the resected greater omentum.


2018 ◽  
Vol 64 (2) ◽  
pp. 228-233
Author(s):  
Vladimir Lubyanskiy ◽  
Vasiliy Seroshtanov ◽  
Ye. Semenova

The aim: To analyze results of surgical treatment of patients with chronic pancreatitis (CP) and to assess the causes of pancreatic cancer after surgical treatment. Materials and methods: 137 patients had duodenum-preserving resections of the pancreas. Results: In the histological examination of the pancreas it was established that the growth of fibrous tissue was registered in patients with CP., which in 19 (13.8%) almost completely replaced the acinar tissue. In the long term after the operation from 6 months to 2 years in 8 patients (5.8%) pancreatic cancer was detected. Possible causes of tumor origin were analyzed, the value of preservation of ductal hypertension, which affects the state of the duct’s epithelium, was established. The most commonly used for treatment of chronic pancreatitis the Frey surgery removed pancreatic hypertension but in two patients during the operation an insufficient volume of the pancreatic head was reconstructed. In the case of the abandonment of a large array of fibrous tissue, local hypertension was retained in the region of the ductal structures of the head, which led to the transformation of the duct epithelium. An essential factor in the problem of the preservation of pancreatic hypertension were the stenosis of pancreatic intestinal anastomoses, they arose in the long term in 4 operated patients. With stenosis of anastomosis after duodenum-preserving resection both the hypertension factor and the regeneration factor could be realized, which under certain circumstances might be significant. Conclusion: After resection of the pancreas for CP cancer was diagnosed in 5.8% of patients. The main method of preventing the risk of cancer was performing the Frey surgery for CP eliminating pancreatic hypertension in the head region of the pancreas. Diagnosis of stenosis in the late period after resection of the pancreas was an important element in the prevention of recurrence of cancer since a timely reconstructive operation could improve the drainage of duct structures.


2021 ◽  
Vol 32 ◽  
pp. S318
Author(s):  
Maeda Shingo ◽  
Ryoji Takada ◽  
Kenji Ikezawa ◽  
Kazuma Daiku ◽  
Yutaro Abe ◽  
...  

2007 ◽  
Vol 33 (7) ◽  
pp. 817-823 ◽  
Author(s):  
J. Kleeff ◽  
C.W. Michalski ◽  
H. Friess ◽  
M.W. Büchler

2007 ◽  
Vol 15 (1) ◽  
pp. 175-185 ◽  
Author(s):  
Anand Govindarajan ◽  
Jensen C. C. Tan ◽  
Nancy N. Baxter ◽  
Natalie G. Coburn ◽  
Calvin H. L. Law

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