scholarly journals ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ken-ichi Okada ◽  
Manabu Kawai ◽  
Seiko Hirono ◽  
Masayuki Sho ◽  
Masaji Tani ◽  
...  

Abstract Background Radical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissected, followed by median-to-left retroperitoneal dissection. This procedure has the potential to isolate blood and lymphatic flow to the area of the pancreatic body/tail and the spleen to be excised. This is achieved by division of the inflow artery, transection of the pancreas, and then division of the outflow vein in the early phases of surgery. In cases of pancreatic ductal adenocarcinoma (PDAC), the procedure has been shown to decrease intraoperative blood loss and increase R0 resection rate by complete clearance of the lymph nodes. This trial investigates whether the isolation procedure can prolong the survival of patients with pancreatic ductal adenocarcinoma who undergo distal pancreatosplenectomy (DPS) compared with those that undergo the conventional approach. Methods/design Patients with PDAC scheduled to undergo DPS are randomized before surgery to undergo either a conventional procedure (arm A) or to undergo the isolation procedure (arm B). In arm A, the pancreatic body, tail, and spleen are mobilized, followed by removal of the regional lymph nodes. The splenic vein is transected at the end of the procedure. The timing of division of the splenic artery (SA) is not restricted. In arm B, regional lymph nodes are dissected, then we transect the root of the SA, the pancreas, then the splenic vein. At the end of the procedure, the pancreatic body/tail and spleen are mobilized and removed. In total, 100 patients from multiple Japanese high-volume centers will be randomized. The primary endpoint is 2-year recurrence-free survival by intention-to-treat analysis. Secondary endpoints include intraoperative blood loss, R0 resection rate, and overall survival. Discussion If this trial shows that the isolation procedures can improve survival with a similar R0 rate and with a similar number of lymph node dissections to the conventional procedure, the isolation procedure is expected to become a standard procedure during DPS for PDAC. Conversely, if there were no significant differences in endpoints between the groups, it would demonstrate justification of either procedure from surgical and oncological points of view. Trial registration UMIN Clinical Trials Registry UMIN000041381. Registered on 10 August 2020. ClinicalTrials.gov NCT04600063. Registered on 22 October 2020.

2020 ◽  
Vol 2020 (7) ◽  
Author(s):  
Takashi Miyata ◽  
Hiroyuki Takamura ◽  
Ryosuke Kin ◽  
Hisashi Nishiki ◽  
Akifumi Hashimoto ◽  
...  

Abstract A 48-year-old woman was admitted to our hospital because of upper abdominal pain. Computer tomography showed an enhancing mass in the pancreatic body, dilation of the main pancreatic duct (MPD) and a filling defect within the splenic vein. On the basis of the preoperative diagnosis of pancreatic body cancer, distal pancreatectomy was scheduled. The pancreas was divided along the left edge of the gastroduodenal artery; however, frozen pathological examination of the pancreatic stump was tumor positive, and therefore a total pancreatectomy was performed. The lesion was a white expansive nodular mass that had spread into the MPD and protruded into the splenic vein. A pathological diagnosis of non-functioning neuroendocrine tumor (NET) was made. In general, imaging findings of disruption of the MPD and tumor vein thrombus are characteristics of pancreatic ductal adenocarcinoma, but are uncommon in NET. However, NET should be included in the differential diagnosis for such patients.


2019 ◽  
Vol 13 (2) ◽  
pp. 245-252 ◽  
Author(s):  
José Miguel Baião ◽  
Rui Miguel Martins ◽  
João Guardado Correia ◽  
Daniel Jordão ◽  
Teresa Vieira Caroço ◽  
...  

A 78-year-old woman was admitted to our hospital with a pancreatic tumor, incidentally discovered in an abdominal ultrasound exam. She was asymptomatic and without any previous personal pathological condition. The computed tomography (CT) and the magnetic resonance imaging (MRI) scan showed a mass lesion of 4 cm in diameter, located in the pancreatic body, conditioning the invasion of the splenic vein. The patient was admitted to surgery. During the laparotomy, we found a tumoral lesion highly suspicious of pancreatic neoplasia located in the transition of the head/body of the pancreas, with an invasion of the portal vein and several peri-regional lymph nodes. We performed biopsies of the pancreatic mass and lymphadenectomy of the peri-regional pancreatic lymph nodes. Histological analysis found an inflammatory pseudotumor of the head/body of the pancreas, without signals of malign epithelial neoplasm and also without criteria for immunoglobulin G4-related disease. During the follow-up, a PET/CT and MRI confirmed that the pancreatic lesion had disappeared without any treatment. Inflammatory pseudotumor of the pancreas is a rare entity not fully understood. Despite this, the administration of corticosteroids and immunosuppressive therapy could be taken into consideration as the disease carries a risk.


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Tiffany A. Pompa ◽  
William F. Morano ◽  
Chetan Jeurkar ◽  
Hui Li ◽  
Suganthi Soundararajan ◽  
...  

Surgery is the only chance for cure in pancreatic ductal adenocarcinoma. In unresectable, locally advanced pancreatic cancer (LAPC), the National Comprehensive Cancer Network (NCCN) suggests chemotherapy and consideration for radiation in cases of unresectable LAPC. Here we present a rare case of unresectable LAPC with a complete histopathological response after chemoradiation followed by surgical resection. A 54-year-old female presented to our clinic in December 2013 with complaints of abdominal pain and 30-pound weight loss. An MRI demonstrated a mass in the pancreatic body measuring6.2×3.2 cm; biopsy revealed proven ductal adenocarcinoma. Due to splenic vein/artery and contiguous celiac artery encasement, she was deemed surgically unresectable. She was started on FOLFIRINOX therapy (three cycles), intensity modulated radiation to a dose of 54 Gy in 30 fractions concurrent with capecitabine, followed by FOLFIRI, and finally XELIRI. After 8 cycles of ongoing XELIRI completed in March 2015, restaging showed a remarkable decrease in tumor size, along with PET-CT revealing no FDG-avid uptake. She was reevaluated by surgery and taken for definitive resection. Histopathological evaluation demonstrated a complete R0 resection and no residual tumor. Based on this patient and literature review, this strategy demonstrates potential efficacy of neoadjuvant chemoradiation with prolonged chemotherapy, followed by surgery, which may improve outcomes in patients deemed previously unresectable.


2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Fredrik Klevebro ◽  
Piers R Boshier ◽  
Carmen Mueller ◽  
Jonathan Cools-Lartigue ◽  
Lorenzo Ferri ◽  
...  

Abstract   The aim of the study was to evaluate short-term and oncological outcomes of left thoracoabdominal esophagectomy (LTE) compared to minimally invasive esophagectomy for cancer of the esophagus and gastroesophageal junction. LTE facilitates complete resection of esophageal cancer particularly for bulky tumors, but there are concerns that this approach is associated with significant morbidity. Methods Prospectively entered esophagectomy databases from two high volume North American centers were reviewed for patients undergoing LTE or MIE in the 2012–2018. Patient demographics, tumour characteristics, operative outcomes, postoperative outcomes, and pathologic surrogates of oncologic efficacy (R0 resection rate, and number of resected lymph nodes) were compared. In total 247 patients were included in the study, LTE was applied in 170 (68.8%) patients, and MIE in 77 (31.2%) patients. Results LTE patients had more neoadjuvant treatment (LTE = 78.2%, MIE = 34.2%, P < 0.001). There was no difference in overall postoperative complications (LTE = 56.9%, MIE = 55.0%, P = 0.799), severe complications (Clavien Dindo>2—LTE = 26.1%, MIE17.0%, P = 0.184), pulmonary complications (LTE = 31.9%, MIE = 20.0%, P = 0.085), pneumonia (LTE = 15.2%, MIE = 13.6%, P = 0.768), anastomotic leak (LTE = 7%, MIE = 10%, P = 0.396), or postoperative mortality (LTE = 0%, MIE = 1.3%, P = 0.140). Median length of stay was 7 days in both groups. R0 resection rate was 93.8% and 95.5% respectively (P = 0.631). Median number of resected lymph nodes was 24 for LTE and 22 for MIE (P = 0.226). LTE had more stage II-IV tumors (LTE = 67.8%, MIE = 40.7%, P < 0.001), and more node positive resections (LTE = 52.5%, MIE = 31.4%, P = 0.003). Conclusion LTE was used for larger tumors with greater lymph node burden in patients that were more likely to have received neoadjuvant treatment compared to MIE. Despite this the postoperative morbidity was equal to that of MIE, with no difference in short-term or oncological results in this cohort.


2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
F Klevebro ◽  
P Boshier ◽  
C Mueller ◽  
J Cools-Lartigue ◽  
L Ferri ◽  
...  

Abstract Aim To evaluate short-term and oncological outcomes of left thoracoabdominal esophagectomy compared to minimally invasive esophagectomy for cancer of the esophagus and gastroesophageal junction Background and Methods Left thoracoabdominal esophagectomy (LTE) facilitates complete resection of esophageal cancer particularly for bulky tumors, but there are concerns that this approach is associated with significant morbidity. Prospectively entered esophagectomy databases from two high volume North American centers were reviewed for patients undergoing LTE or MIE in the 2012-2018. Patient demographics, tumour characteristics, operative outcomes, postoperative outcomes, and pathologic surrogates of oncologic efficacy (R0 resection rate, and number of resected lymph nodes) were compared. Results In total 247 patients were included in the study, LTE was applied in 170 (68.8%) patients, and MIE in 77 (31.2%) patients. LTE patients had more neoadjuvant treatment (LTE=78.2%, MIE=34.2%, P<0.001). There was no difference in overall postoperative complications (LTE=56.9%, MIE=55.0%, P=0.799), severe complications (Clavien Dindo>2 - LTE=26.1%, MIE17.0%, P=0.184), pulmonary complications (LTE=31.9%, MIE=20.0%, P=0.085), pneumonia (LTE=15.2%, MIE=13.6%, P=0.768), anastomotic leak (LTE=7%, MIE=10%, P=0.396), or postoperative mortality (LTE=0%, MIE=1.3%, P=0.140). Median length of stay was 7 days in both groups. R0 resection rate was 93.8% and 95.5% respectively (P=0.631). Median number of resected lymph nodes was 24 for LTE and 22 for MIE (P=0.226). LTE had more stage II-IV tumors (LTE=67.8%, MIE=40.7%, P<0.001), and more node positive resections (LTE=52.5%, MIE=31.4%, P=0.003). Conclusion LTE was used for larger tumors with greater lymph node burden in patients that were more likely to have received neoadjuvant treatment compared to MIE. Despite this the postoperative morbidity was equal to that of MIE, with no difference in short-term or oncological results in this cohort.


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ren-Chao Zhang ◽  
Xin-Jun Gan ◽  
Wei Song ◽  
Song-Tao Shi ◽  
Hui-Fang Yu ◽  
...  

Abstract Background The radical antegrade modular pancreatosplenectomy (RAMPS) which is a reasonable surgical approach for left-sided pancreatic cancer is emphasis on the complete resection of regional lymph nodes and tumor-free margin resection. Laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) has been rarely performed, with only 49 cases indexed on PubMed. In this study, we present our experience of LRAMPS. Methods From December 2018 to February 2020, 10 patients underwent LRAMPS for pancreatic cancer at our department. The data of the patient demographics, intraoperative variables, postoperative hospital stay, morbidity, mortality, pathologic findings and follow-up were collected. Results LRAMPS was performed successfully in all the patients. The median operative time was 235 min (range 212–270 min), with an EBL of 120 ml (range 100–200 ml). Postoperative complications occurred in 5 (50.0%) patients. Three patients developed a grade B pancreatic fistula. There was no postoperative 30-day mortality and reoperation. The median postoperative hospital stay was 14 days (range 9–24 days).The median count of retrieved lymph nodes was 15 (range 13–21), and four patients (40%) had malignant-positive lymph nodes. All cases achieved a negative tangential margin and R0 resection. Median follow-up time was 11 months (range 3–14 m). Two patients developed disease recurrence (pancreatic bed recurrence and liver metastasis) 9 months, 10 months after surgery, respectively. Others survived without tumor recurrence or metastasis. Conclusions LRAMPS is technically safe and feasible procedure in well-selected patients with pancreatic cancer in the distal pancreas. The oncologically outcomes need to be further validated based on additional large-volume studies.


2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Marina Likos-Corbett ◽  
Pranav Patel ◽  
Rachna Goburdhun ◽  
Satvinder Mudan ◽  
Amir Khan ◽  
...  

Abstract Background Pancreatic ductal adenocarcinoma (PDAC) is associated with a historically poor long-term survival of 5-10%, despite surgical resection. Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) is reported as potentially resectable disease with a degree of vascular involvement, increasing the risk of a positive surgical margin. This cohort of patients have the worst survival despite curative resection and adjuvant chemotherapy. Emerging evidence suggests that neo-adjuvant chemoradiation (NCR) improves R0 resection rates in BR-PDAC patients. We evaluated the R0 resection rate, disease free survival (DFS) and overall survival (OS) in our patients, who had undergone NCR for BR-PDAC at our institution. Methods Data was collected retrospectively for all patients undergoing NCR for BR-PDAC between Jan 2010 to Mar 2020 for this study. Surgical management was ratified by clinical assessment and cross-sectional imaging in a pancreatic multidisciplinary team meeting (MDM). Patients underwent NCR by a number of standardised regimens. Patients with proven regressive or stable disease on imaging underwent a pancreatic resection. All BR-PDAC patients underwent resection in the form of classical Whipple’s or pylorus preserving pancreaticoduodenectomy (PPPD) depending on intra-operative findings. Patient morbidity, R0 resection rate, histological parameters, DFS and OS were evaluated. Results 29 patients were included in the study (16 men and 13 women), with a median age of 65 years (range, 46-74 years). 17 patients received FOLFIRINOX and 12 patients received gemcitabine (GEM) based NCR regimens. All patients received chemoradiation at the end of chemotherapy (range 45-56Gy). 75% had an R0 resection, with a greater proportion in the FOLFIRINOX group. Whole cohort median DFS was 35 months, survival was superior in the FOLFIRINOX group (42 months). Median OS was 30 months for the whole group, with a greater median OS in the FOLFIRINOX versus the GEM cohort (42 versus 29 months). Conclusions We present a single centre retrospective study utilising NCR for BR-PDAC, we reiterate the strong association of an R0 resection with superior patient overall survival following surgery in this cohort. We show that in patients with BR-PDAC, NCR results in superior R0 resection rates with an associated increase in patient survival. Our results show that survival advantage is greatest in BR-PDAC patients who received neo-adjuvant FOLFIRINOX.  Our findings affirm the advantage of NCR prior to surgery, particularly FOLFIRINOX based treatment, in this cohort of patients.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 189-189 ◽  
Author(s):  
Michiaki Unno ◽  
Fuyuhiko Motoi ◽  
Yutaka Matsuyama ◽  
Sohei Satoi ◽  
Ippei Matsumoto ◽  
...  

189 Background: Despite improvements of postoperative adjuvant therapy for resected pancreatic ductal adenocarcinoma (PDAC), its prognosis remains poor. A randomized controlled trial has begun to compare neoadjuvant chemotherapy using gemcitabine and S1 (NAC-GS) with upfront surgery (Up-S) for patients with PDAC planned resection. Methods: Patients were enrolled after the diagnosis of resectable PDAC with histological confirmation. They were randomly assigned as either NAC-GS or Up-S. In NAC-GS, gemcitabine was provided at a dose of 1 g/m2 on day 1 and 8 and oral S-1 was administered at a dose of 40 mg/m2 twice daily on 1-14 days. Patients received 2 cycles of this regimen. S-1 adjuvant for 6 months was administered for the patients with curative resection and fully recovered within 10 weeks after surgery in both arms. The primary endpoint for the phase III part was overall survival (OS); secondary endpoints included adverse events, resection rate, recurrence-free survival, residual tumor status, nodal metastases, and tumor marker kinetics. The target sample size required 163 patients (α-error 0.05; power 0.8) in each arm. The trial was conducted by the Health Labor Sciences Research Grant (H22-009) of Japan and registered with the UMIN Clinical Trials Registry as UMIN000009634. Results: From January 2013 to January 2016, 364 patients were enrolled in 57 centers (182 to NAC-GS and 182 to Up-S). Of these, two were excluded because of ineligibility, therefore 182 patients in NAC-GS and 180 in Up-S constituted the ITT analysis-set. The median OS was 36.7 months in NAC-GS and 26.6 months in Up-S; HR 0.72 (95% confidential interval 0.55-0.94; p=0.015 [stratified log-rank test]). Grade 3 or 4 adverse events frequently (72.8%) observed in NAC-GS were leukopenia or neutropenia. However, the resection rate, R0 resection rate, and morbidity of the operation were equivalent in the two groups. There was no perioperative mortality in either group. Conclusions: This phase III study demonstrated the significant survival benefits of NAC-GS treatment. Therefore, the results indicated that neoadjuvant chemotherapy could be a new standard for patients with resectable PDAC. Clinical trial information: UMIN000009634.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4638-4638
Author(s):  
Michael Wysota ◽  
Amanda Jirgal ◽  
Ana Acuna-Villaorduna ◽  
Shankar Viswanathan ◽  
Andreas Kaubisch ◽  
...  

4638 Background: Preoperative (preop) therapy is widely accepted as the standard of care for patients (pt) with BR PDAC with limited evidence for a specific regimen. This study aimed to assess the efficacy of FOLFIRINOX (FOL) chemotherapy followed by gemcitabine-based chemo-radiotherapy (RT) as preop therapy in pt with BR-PDAC. Methods: This single arm Simon two stage phase II trial in pt with BR PDAC was conducted in two phases. The first phase included 4 cycles of FOL, and the second included weekly gemcitabine (1000 mg/m2) for 6 cycles with concomitant intensity-modulated RT (50.4 Gy in 28 fractions)(Gem/RT).The primary aim was to compare R0 resection rate (H0: ≤40% vs Ha≥60%) using one-sample one-sided Z test. Secondary outcomes, including overall survival (OS) and progression-free survival (PFS) were assessed using Kaplan-Meier method. Results: Of 22 enrolled pt, 18 (81.8%) completed preoperative treatment. Median age at diagnosis was 63.4 years and 12 (54.5%) were female. There were 10 (45.5%) Hispanics, 4 (18.2%) non-Hispanic black, and 8 (36.4%) non-Hispanic white. Tumor location was predominantly head/neck (21, 95.5%), 15 (68.1%) had T2/3, and 9 (40.9%) had N2 (clinical) disease. Fourteen (64.6%) pt, had venous involvement, 5 (22.7%) had arterial, and 3 (13.6%), both. In the first phase, 20 (90.9%) completed 4 cycles of FOL, 6 (27.3%) required dose-reduction and dose was delayed in 12 (54.5%). Stable disease (SD) was achieved in 10 (52.6%), partial response (PR) in 8 (42.1%) and disease progression (PD) in 1 (5.3%) pt. Of 21 pt that entered the second phase, 18 (85.7%) completed 6 cycles of Gem/RT, 5 (26.3%) required dose-reduction and dose was delayed in 6 (31.6%). SD was achieved in 10 (55.6%), PR in 3 (16.7%) and PD in 5 (27.8%). All pt experienced at least one grade 1 adverse event (AE) and 12 (54.5%) at least one grade 3/4 AE, of which neutropenia was the most common-11 (50%). Of the 15 (68.1%) pt who underwent surgical resection, 12 (80%) achieved R0 margins and 5 (33.3%) required vascular reconstruction. The R0 rate among pt that received >1 cycle of FOLFIRINOX was 54.5%. Adjuvant chemotherapy was offered to 6/15 pt (40%). The PFS and OS will be reported. Conclusions: An R0 resection rate of 54.5% with this limited sample size is significant at the 10% level. Neoadjuvant FOLFIRINOX followed by concomitant Gem/RT was well-tolerated. The study will be amended to include adjuvant FOL in line with the PRODIGE intergroup adjuvant study results. Clinical trial information: NCT01897454 .


2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Fredrik Klevebro ◽  
Shiwei Han ◽  
Stephen Ash ◽  
C Mueller ◽  
Jonathan Cools-Lartigue ◽  
...  

Abstract   Left thoracoabdominal esophagectomy (LTE) facilitates complete resection of esophageal cancer particularly for bulky tumors, but there are concerns that this approach is associated with significant morbidity. The aim of the current study was to evaluate short-term and oncological outcomes of left thoracoabdominal esophagectomy compared to minimally invasive esophagectomy for cancer of the esophagus and gastroesophageal junction. Methods Prospectively entered esophagectomy databases from three high volume centers were reviewed for patients undergoing LTE or MIE 2012–2018. Patient demographics, tumour characteristics, operative outcomes, postoperative outcomes, and pathologic surrogates of oncologic efficacy (R0 resection rate, and number of resected lymph nodes) were compared. In total 844 patients were included in the study, LTE was applied in 654 (77.5%) patients, and MIE in 190 (22.5%) patients. Results LTE patients had more neoadjuvant treatment (LTE = 74.5%, MIE = 64.9%, P = 0.027). There was no difference in overall postoperative complications (LTE = 61.9%, MIE = 64.6%, P = 0.517), severe complications (Clavien Dindo &gt;IIIa (LTE = 26.6%, MIE 26.5%, P = 0.982), pneumonia (LTE = 29.8%, MIE = 26.3%, P = 0.349), anastomotic leak (LTE = 7.7%, MIE = 9.9%, P = 0.348), or in-hospital mortality (LTE = 1.5%, MIE = 2.1%, P = 0.584). Median length of stay was 11 days after LTE vs. 8 days after MIE (P &lt; 0.001). R0 resection rate was 92.4% and 95.6% respectively (P = 0.144). Median number of resected lymph nodes was 25 for LTE and 28 for MIE (P = 0.017). LTE had more node positive resections (LTE = 57.6%, MIE = 44.0%, P = 0.001). Conclusion LTE was used for tumors with greater lymph node burden in patients that were more likely to have received neoadjuvant treatment compared to MIE. MIE was associated with significantly shorter length of hospital stay, however postoperative morbidity and Clavien-Dindo scores were equal to that of MIE in this cohort.


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