Incidence Of Clavien-Dindo Grade Research Articles

Oncologic investigation of the interval from stent placement to surgery in patients with obstructive colorectal cancer.

Self-expandable metallic stent (SEMS) placement is widely used as a bridge to surgery (BTS) procedure for obstructive colorectal cancer. However, evidence regarding the optimal interval between SEMS placement and elective surgery is lacking. We retrospectively collected data from patients with BTS between January 2013 and October 2021. Inverse probability treatment-weighted propensity score analyses were used to compare short- and long-term outcomes between the short-interval (SI) and long-interval (LI) groups, using a cutoff of 20days. In total, 138 patients were enrolled in this study (SI group, n = 63; LI group, n = 75). In the matched cohort, the patients' backgrounds were well balanced. The incidence of Clavien-Dindo grade ≥ II postoperative complications was not significantly different between the SI and LI groups (19.0% vs. 14.0%, P = 0.47). There were no significant differences between the SI and LI groups in the 3-year recurrence-free survival (68.0% vs. 76.4%, P = 0.73) or 3-year overall survival rates (86.0% vs. 90.6%, P = 0.72). A longer interval did not deteriorate the oncological outcomes. Individual perioperative management with an appropriate interval to improve the patient's condition is required to ensure safe surgery.

Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 gastric cancer patients (JCOG1907, MONA LISA study): a study protocol

BackgroundLaparoscopic gastrectomy (LG) is considered a standard treatment for clinical stage I gastric cancer. Nevertheless, LG has some drawbacks, such as motion restriction and difficulties in spatial perception. Robot-assisted gastrectomy (RG) overcomes these drawbacks by using articulated forceps, tremor-filtering capability, and high-resolution three-dimensional imaging, and it is expected to enable more precise and safer procedures than LG for gastric cancer. However, robust evidence based on a large-scale randomized study is lacking.MethodsWe are performing a randomized controlled phase III study to investigate the superiority of RG over LG for clinical T1-2N0-2 gastric cancer in terms of safety. In total, 1,040 patients are planned to be enrolled from 46 Japanese institutions over 5 years. The primary endpoint is the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreatic fistula, and intra-abdominal abscess of Clavien–Dindo (CD) grade ≥ II. The secondary endpoints are the incidence of all CD grade ≥ II and ≥ IIIA postoperative complications, the incidence of CD grade ≥ IIIA postoperative intra-abdominal infectious complications, relapse-free survival, overall survival, the proportion of RG completion, the proportion of LG completion, the proportion of conversion to open surgery, the proportion of operation-related death, and short-term surgical outcomes. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in January 2020. Approval from the institutional review board was obtained before starting patient enrollment in each institution. Patient enrollment began in March 2020. We revised the protocol to expand the eligibility criteria to T1-4aN0-3 in July 2022 based on the results of randomized trials of LG demonstrating non-inferiority of LG to open surgery for survival outcomes in advanced gastric cancer.DiscussionThis is the first multicenter randomized controlled trial to confirm the superiority of RG over LG in terms of safety. This study will demonstrate whether RG is superior for gastric cancer.Trial registrationThe protocol of JCOG1907 was registered in the UMIN Clinical Trials Registry as UMIN000039825 (http://www.umin.ac.jp/ctr/index.htm). Date of Registration: March 16, 2020. Date of First Participant Enrollment: April 1, 2020.

Transarterial chemoembolization for liver metastases of a pancreatic neuroendocrine neoplasm: a single-center experience.

Transarterial chemoembolization (TACE) is performed for pancreatic neuroendocrine tumor (PanNEN) liver metastases; however, the safety and efficacy of TACE procedures, especially for patients who have undergone previous pancreatic surgery, have not been established. We reviewed 48 TACE procedures (1-6 procedures/patient) performed on 11 patients with PanNEN liver metastases, including 16 TACE procedures (4-6 procedures/patient) for 3 patients with a history of biliary-enteric anastomosis. The overall tumor objective response rate was 94%. The incidence of Clavien‒Dindo grade ≥ 2 complications was 1/16 (6%) and 1/32 (3%), and the median time to untreatable progression was 31 (14-41) and 27 (2-60) months among patients with and without a history of biliary-enteric anastomosis, respectively. Although validation is needed in future studies, our experiences have shown that TACE treatment is a viable treatment option for PanNEN liver metastases, even after biliary-enteric anastomosis with experienced teams and careful patient follow-up.

Efficacy and Postoperative Outcomes of Laparoscopic Retrosternal Route Creation for the Gastric Conduit: Propensity Score-Matched Comparison to Posterior Mediastinal Reconstruction.

Retrosternal reconstruction has lower risks for severe postoperative morbidities, such as gastro-tracheal fistula or esophageal hiatal hernia. We have previously reported the laparoscopic retrosternal route creation (LRRC) method, but its safety and efficacy remain unclear. In total, 374 patients with esophageal carcinoma who underwent minimally invasive McKeown esophagectomy in the prone position between 2010 and 2021 were retrospectively reviewed. We performed a propensity score-matched analysis with the simple, nearest-neighbor method and no calipers to compare postoperative outcomes and reconstructed gastric conduit functionality between patients who underwent LRRC and counterparts who underwent posterior mediastinal reconstruction. After matching, 62 patients were included in the laparoscopic retrosternal group (LR group) or posterior mediastinal group (PM group). No significant differences were observed between the groups, apart from the number of robot-assisted surgeries, the extent of lymph node dissection, and the method of cervical anastomosis. There were no significant differences in the incidence of Clavien-Dindo grade ≥ 2 complications. Gastro-tracheal fistula (n = 1) and esophageal hiatal hernia (n = 2) occurred in the PM group but not in the LR group. There were no differences in the incidence of pulmonary embolism between the groups (5% vs. 5%). The postoperative anastomotic stenosis rate was similar (16% vs. 27%, p = 0.192). Endoscopic findings of reflux esophagitis (modified Los Angeles classification≥ M) at 1 year after surgery were significantly better in the LR group (p = 0.037). LRRC for gastric conduit reconstruction is safe and valuable. It is associated with good reconstructed gastric conduit function.

Comparison of Laparoscopic and Open Gastrectomy for Patients With Gastric Cancer Treated With Neoadjuvant Chemotherapy: A Multicenter Retrospective Study Based on the Korean Gastric Cancer Association Nationwide Survey.

Despite scientific evidence regarding laparoscopic gastrectomy (LG) for advanced gastric cancer treatment, its application in patients receiving neoadjuvant chemotherapy remains uncertain. We used the 2019 Korean Gastric Cancer Association nationwide survey database to extract data from 489 patients with primary gastric cancer who received neoadjuvant chemotherapy. After propensity score matching analysis, we compared the surgical outcomes of 97 patients who underwent LG and 97 patients who underwent open gastrectomy (OG). We investigated the risk factors for postoperative complications using multivariate analysis. The operative time was significantly shorter in the OG group. Patients in the LG group had significantly less blood loss than those in the OG group. Hospital stay and overall postoperative complications were similar between the two groups. The incidence of Clavien-Dindo grade ≥3 complications in the LG group was comparable with that in the OG group (1.03% vs. 4.12%, P=0.215). No statistically significant difference was observed in the number of harvested lymph nodes between the two groups (38.60 vs. 35.79, P=0.182). Multivariate analysis identified body mass index (odds ratio [OR], 1.824; 95% confidence interval [CI], 1.029-3.234; P=0.040) and extent of resection (OR, 3.154; 95% CI, 1.084-9.174; P=0.035) as independent risk factors for overall postoperative complications. Using a large nationwide multicenter survey database, we demonstrated that LG and OG had comparable short-term outcomes in patients with gastric cancer who received neoadjuvant chemotherapy.

Clinical analysis of inflatable video-assisted mediastinoscopic transhiatal esophagectomy combined with laparoscopy

Objective: To examine the safety and effectiveness of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE). Methods: Totally 269 patients admitted to the Anhui Provincial Hospital of Anhui Medical University who underwent IVMTE (IVMTE group, n=47) or thoracoscopy combined with minimally invasive Mckeown esophageal cancer resection (MIME group, n=222) from September 2017 to December 2021 were analyzed retrospectively. There were 31 males and 16 females in IVMTE group, aged (68.6±7.5) years (range: 54 to 87 years). There were 159 males and 63 females in MIME group, aged (66.8±8.8) years (range: 42 to 93 years). A 1∶1 match was performed on both groups by propensity score matching, with 38 cases in each group. The intraoperative conditions and postoperative complication rates of the two groups were compared by t test, Wilcoxon rank, χ2 test, or Fisher exact probability method. Results: Patients in IVMTE group had less intraoperative bleeding ((96.0±39.2) ml vs. (123.8±49.3) ml, t=-2.627, P=0.011), shorter operation time ((239.1±47.3) minutes vs. (264.2±57.2) minutes, t=-2.086, P=0.040), and less drainage 3 days after surgery (85(89) ml vs. 675(573) ml, Z=-7.575, P<0.01) compared with that of MIME group. There were no statistically significant differences between the two groups in terms of drainage tube-belt time, postoperative hospital stay, and lymph node dissection stations and numbers (all P>0.05). The incidence of Clavien-Dindo grade 1 to 2 pulmonary infection (7.9%(3/38) vs. 31.6%(12/38), χ²=6.728, P=0.009), total complications (21.1%(8/38) vs. 47.4%(18/38), χ²=5.846, P=0.016) and total lung complications (13.2%(5/38) vs. 42.1%(16/38), χ²=7.962, P=0.005) in the IVMTE group were significantly lower. Conclusion: Inflatable video-assisted mediastinoscopic transhiatal esophagectomy combined with laparoscopic esophagectomy is safe and feasible, which can reach the same range of oncology as thoracoscopic surgery.

Optimal timing of portal vein embolization (PVE) after preoperative biliary drainage for hilar cholangiocarcinoma.

Preoperative biliary drainage (PBD) followed by portal vein embolization (PVE) has increased the chance of resection for hilar cholangiocarcinoma (CCC). We aim to identify the optimal timing of PVE after PBD in patients undergoing hepatectomy for hilar CCC. We retrospectively reviewed 64 patients who underwent hepatectomy after PBD and PVE for hilar CCC. The patients were classified into 3 groups: Group 1 (PBD-PVE interval ≤7 days), Group2 (8-14 days) and Group 3 (>14 days). The primary end points were 90 days mortality and grade B/C posthepatectomy liver failure (PHLF). There was no significant difference in primary end points between three groups. A marginally significant difference was found in the incidence of Clavien-Dindo grade ≥3 complications and wound infection (57.1% vs 38.1% vs 72.4%, p=0.053 and 21.4% vs 38.1% vs 55.2%, p=0.099). In multivariable analysis, Bismuth type IIIb or IV was independent risk factors for grade B/C PHLF (HR: 4.782, 95% CI 1.365-16.759, p=0.014). Considering that the PBD-PVE interval did not affect PHLF, and the surgical complications increased as the interval increases, PVE as early as possible after PBD would be beneficial.

Use of near-infrared imaging using indocyanine green associates with the lower incidence of postoperative complications for intestinal and mesenteric injury

Anastomotic leakage after intestinal resection is one of the most serious complications of surgical intervention for hollow viscus injury. Adequate vascular perfusion of the anastomotic site is essential to prevent anastomotic leakage. Near-infrared imaging using indocyanine green (NIR-ICG) is useful for the objective assessment of vascular perfusion. The aim of this study was to evaluate the association of NIR-ICG with intestinal and mesenteric injuries. This was a retrospective, single-center study of patients undergoing surgery for intestinal and mesenteric injuries. NIR-ICG was used to evaluate vascular perfusion. Postoperative complications were assessed between NIR-ICG and non-NIR-ICG groups.The use of NIR-ICG was associated with a lower incidence of Clavien-Dindo grade ≥ III complications with a statistical tendency (p = 0.076). When limited to patients that underwent intestinal resection, the use of NIR-ICG was significantly associated with a lower risk of perioperative complications (p = 0.009). The use of NIR-ICG tended to associate with the lower incidence of postoperative complications after intestinal and mesenteric trauma surgery. NIR-ICG was associated with a significantly lower risk of complications in patients undergoing intestinal resection. The NIR-ICG procedure is simple and quick and is expected to be useful for intestinal and mesenteric trauma.

Early Drain Removal is Safe in Patients With Low or Intermediate Risk of Pancreatic Fistula After Pancreaticoduodenectomy: A Multicenter, Randomized Controlled Trial.

This multicenter randomized controlled trial was designed to test the hypothesis that early drain removal (EDR) could decrease the incidence of grade 2 to 4 complications for patients undoing pancreaticoduodenectomy (PD) with low or intermediate risk of postoperative pancreatic fistula (POPF). The safety and effects of EDR on postoperative complications after PD are still controversial. A multicenter randomized controlled trial at 6 tertiary referral hospitals was carried out (NCT03055676). Patients who met the inclusion criteria, including drain amylase level less than 5000 U/L on postoperative day (POD) 1 and POD 3, and drain output less than 300 mL per day within 3 days after surgery, were enrolled. Patients were then randomized to the EDR group or the routine drain removal (RDR) group. In the EDR group, all drainage tubes were removed on POD3. In the RDR group, drainage tubes were removed on POD 5 or beyond. Primary outcome was the incidence of Clavien-Dindo grade 2 to 4 complications. Secondary outcomes were comprehensive complication index, grade B/C POPF, total medical expenses and postoperative in-hospital stay etc, within 90 days after surgery. A total of 692 patients were screened, and 312 patients were eligible for randomization. Baseline characteristics were well balanced between the 2 groups and 96.8% of these 312 patients had low or intermediate risk of POPF, according to the 10-point fistula risk score. A total of 20.5% of the patients in the EDR group suffered at least 1 grade 2 to 4 complication, versus 26.3% in the RDR group (P = 0.229). Multi-variate analysis showed older age (>65 years old) and blood transfusion were independent risk factors for grade 2 to 4 complications. The rate of grade B/C POPF was low in either group (3.8% vs 6.4%, P = 0.305). The comprehensive complication index of the 2 groups was also comparable (20.9 vs 20.9, P = 0.253). Total medical expenses were not significantly different. Postoperative in-hospital stay was clinically similar (15 days vs 16 days, P = 0.010). Nearly half of the patients undergoing PD met the inclusion criteria, predicting low incidence of grade B/C POPF and major complications. EDR was safe in these patients but did not significantly decrease major complications.

Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis A Single-Center, Phase 3, Randomized Clinical Trial

Importance The operative scenarios with the highest postoperative pancreatic fistula (POPF) risk represent situations in which fistula prevention and mitigation strategies have the strongest potential to affect surgical outcomes after pancreaticoduodenectomy. Evidence from studies providing risk stratification is lacking. Objective To investigate whether pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent, is the best reconstruction method for patients at high risk of POPF after pancreaticoduodenectomy. Design, Setting, and Participants A single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score, some of whom were randomized to undergo PG or PJ. All analyses were performed on an intention-to-treat basis. Interventions Intervention consisted of PJ or PG, both with externalized transanastomotic stent and octreotide omission. Main Outcomes and Measures The primary end point was POPF. The secondary end points were Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden. Results A total of 604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n = 36; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n = 36; 26 men and 10 women; median age, 63 years [interquartile range, 35-79]). There was no significant difference in the incidence of POPF between patients who underwent PG and patients who underwent PJ (18 [50.0%] vs 14 [38.9%];P = .48), but for patients who developed a POPF, the mean (SD) average complication burden was lower for those who underwent PJ than for those who underwent PG (0.25 [0.13] vs 0.39 [0.17];P = .04). The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group;P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group;P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%];P = .047). Conclusions and Relevance Among patients at the highest risk for POPF, those who underwent PG or PJ experienced similar rates of POPF. However, PG was associated with an increased incidence of Clavien-Dindo grade 3 or higher morbidity and with an increased average complication burden for the patients who developed a POPF. For patients at high risk for pancreatic fistula, PJ with the use of externalized stent and octreotide omission should be considered the most appropriate technical strategy. Trial Registration ClinicalTrials.gov Identifier:NCT03212196

Safety of laparoscopic total gastrectomy with splenectomy for upper third advanced gastric cancer.

139 Background: In patients with locally advanced gastric cancer, total gastrectomy with splenectomy (TGS) is sometimes indicated when a tumor directly infiltrates the spleen or obvious splenic hilar lymph node metastasis exists. However, this procedure is technically demanding and can cause potentially fatal postoperative pancreas-related complications. TGS has increasingly been performed laparoscopically, particularly in East Asia. However, the number of reports regarding laparoscopic TGS (LTGS) is limited, and thus the feasibility of LTGS remains unclear. Methods: The present study included 68 patients with upper-third advanced gastric cancer who underwent LTGS or conventional open TGS (OTGS) between 2012 and 2018. Clinicopathological characteristics and surgical outcomes were retrospectively reviewed and compared between the groups. Results: There were no significant differences in sex, age, tumor size, cN factor, or cStage. cT4 was less frequently included in the LTGS group (21.4 vs 79.6 %, P &lt; 0.01). In the LTGS group, operating time was longer (332 vs 247 min, P &lt; 0.01) and blood loss was less (38 vs 598 ml, P &lt; 0.01). Incidence of Clavien-Dindo grade 3 or higher complication (0 vs 24.1 %, P = 0.05) and median postoperative hospital stay (9 vs 11 days, P = 0.03) were significantly difference between the groups. The median number of harvested No. 10 and No.11d lymph nodes was equivalent between the groups. Conclusions: LTGS can be a safe procedure provided an experienced surgical team performs the surgery. Oncological safety remains unclear, and needs to be confirmed in future trials.

The impact of tumor differentiation on perioperative outcomes and patterns of recurrence following preoperative therapy for resectable pancreatic adenocarcinoma

Background: Tumor differentiation affects local invasion and patient survival in many cancers. The impact of pancreatic ductal adenocarcinoma (PDAC) differentiation on patterns of recurrence and complications following preoperative therapy and pancreatectomy is poorly defined. Methods: A retrospective analysis of a prospectively maintained database was conducted of all patients who underwent pancreatectomy for PDAC from 2011–2015 following preoperative therapy (chemotherapy, radiation, or combination). Differences in clinicopathologic characteristics, operative details, perioperative complications, overall (OS) and recurrence-free survival (RFS) were compared between patients stratified by tumor differentiation (moderate or poor). Results: Among 156 pancreatectomy patients, 112 (72%) had moderately differentiated (MD) tumors and 44 (28%) poorly differentiated (PD) tumors. The groups had similar demographics, median CA19-9, co-morbidity index, and type of preoperative therapy. Tumor size, T and N stage, lymph node ratio, and incidence of lymphovascular invasion were similar, while perineural invasion was more common in PD than MD tumors(91% vs 76%, p = 0.03). There were no differences in the incidence of Clavien-Dindo grade III/IV complications, rates of grade B or C post-operative pancreatic fistulae or delayed gastric emptying. There were no differences in median OS (32 vs 48 months, p = 0.86), median RFS(16 vs 36 months, p = 0.17), or patterns of recurrence (local, regional, or distant) between MD and PD tumors. Conclusions: Poorly differentiated PDAC is characterized by more frequent or persistent perineural invasion relative to moderately differentiated tumors following preoperative therapy. However, tumor differentiation has no impact on postoperative patterns of local or distant tumor recurrence or the incidence or severity of post-operative complications.Tabled 1Complications Table

Analysis of endophytic renal tumor growth characteristic on the outcomes of robot-assisted laparoscopic partial nephrectomy

Objective To analyze the effect of endophytic renal tumor growth characteristic on the short-term outcomes of robot-assisted laparoscopic partial nephrectomy (RALPN). Methods From March 2015 to October 2016, 23 RALPN cases of endophytic renal masses and 68 RALPN cases of intermediate and exophytic renal tumors were retrospectively analyzed. There were no significant differences in age, gender, tumor side, history of abdominal surgery, benign and malignant cases of the two groups of patients (P>0.05). Patients with a completely endophytic mass had smaller tumors [(2.4±0.5)cm vs.(3.9±1.1)cm], and higher overall R. E.N.A.L. score (P<0.05). The differences of perioperative period and postoperative follow-up results were analyzed. Results All 91 RALPN cases were successfully done without conversion to open or radical nephrectomy. There were no significant differences in intraoperative blood loss, postoperative Hb decrease, intraoperative and postoperative blood transfusion rate, hospital days, positive tumor margins, and the incidence of Clavien-Dindo grade Ⅲ or above in the two groups (P>0.05). The endophytic group showed longer operative time[(95.6± 19.4)min vs.(75.3±16.9)min ], and longer renal warm ischemia [(25.2±5.4)min vs.(17.6±7.0)min]. In the postoperative follow-up of 3 months to 22 months, all patients got disease-free survival. Conclusions RALPN for completely intraparenchymal renal tumors can be safely and effectively performed in experienced institutes. However, the long-term period of follow-up is still missing. Key words: Endophytic renal masses; Robot-assisted laparoscopic; Partial nephrectomy

Surgical complications in 448 gynecological 3D laparoscopic surgeries adopting the Clavien—Dindo classification

The aim of this study is to present and report the perioperative outcomes, intraoperative, and postoperative complications according to the Clavien—Dindo classification. Clinical data of 448 patients who underwent 3D laparoscopy in a single center over 1 year was retrospectively analyzed, and the postoperative complications were stratified adopting the Clavien—Dindo (CD) classification. During the study period, 448 patients underwent gyneclogical 3 D laparoscopic surgery, TLH (259), laparoscopic myomectomy(104), surgery for endometriosis(20), ovarian cyst(24), and miscellaneous(41). The overall rate of intraoperative complications were 0.9 %. There were two cases of bowel injury (0.4 %), one with intra-operative bladder injury (0.2 %) and one with ureteric injury (0.2 %). In all the above cases, recovery was uneventful and no further intervention was needed. There were no incidences of vascular injury, clinical thromboembolism, ICU admission, or death. The incidence of CD Grade I complications was 1.1 %. There were two cases of postoperative vertigo which was treated with betahistine dihydrochloride. One case each of urinary tract infection and vault infection treated with antibiotics and one case of postoperative dysuria treated with flavoxate hydrochloride. Blood transfusions were required in four patients. The incidence of CD Grade II complications was 2.0 %. Two patients (0.4 %) of TLH underwent vault re-suturing under general anesthesia (CD Grade IIIb). There were no cases of CD Grade IV and Grade V complications. The complication rate in our study compares favorably with those reported by other large studies. The authors believe that a widespread implementation of a common standardized system for reporting of complications is essential for comparability of clinical data.