Unresectable Gallbladder Cancer Research Articles

A COMPARATIVE STUDY OF TWO HYPOFRACTIONATED EXTERNAL BEAM RADIATION THERAPY SCHEDULES IN SYMPTOM PALLIATION IN UNRESECTABLE CARCINOMA GALLBLADDER

Introduction: Gallbladder cancer is a highly aggressive cancer, with majority of the patients presenting in advanced stage having a dismal prognosis. Objective: The aim of the study, is to compare the symptom relief, loco-regional tumour response and tolerance between the two different external beam radiation therapy schedules. Methods: A randomized study was conducted for two years including 60 patients. The patients were divided into two arms, with Arm-A receiving a total dose of 33Gy/15# and theArm-B receiving 30Gy/10#. Results: Early tumour response was slightly better in Arm-B than in Arm-A, with 50% patients showing partial response in Arm-B in comparison to 40% in Arm-A. Symptom relief was better and statistically significant in Arm-B with respect to Arm-A. At 3 and 6 month follow up, the symptomatic relief was comparable between the two arms, with 72% patients having relief of nausea/ vomiting in Arm-B with respect to 39.1% patients in Arm-A. The weekly toxicities were almost comparable between the arms, with haematological toxicities being slightly higher in Arm-A as compared to Arm-B. Late treatment related toxicities were also higher in Arm-A as compared to Arm-B. Conclusion: Palliative radiation therapy given to patients, over a short period of time is better in comparison to similarequivalent dose given over longer period of time in symptom palliationfor patients with unresectable gallbladder cancer.

Can laparoscopic surgery be the preferred strategy for gallbladder cancer?

Gallbladder cancer, notoriously known for its high malignancy, predominantly requires radical surgery as the treatment of choice. Although laparoscopic techniques have become increasingly prevalent in abdominal surgeries in recent years, the progress of laparoscopic techniques in gallbladder cancer is relatively slow. Due to the anatomical complexity, technical difficulty, and biological features of gallbladder cancer that is prone to metastasis and dissemination, traditional open surgery is still the main surgical approach. This study aims to reappraisal the current state of laparoscopic surgery for gallbladder cancer by appraising clinical practice and research evidence. Laparoscopic surgery for various stages of gallbladder cancer, including early, advanced, incidental, and unresectable gallbladder cancer were discussed. The promise and limitations of laparoscopic techniques are systematically explored.

Outcomes of Self-expandable Metal Stents in Patients With Unresectable Gallbladder Cancer Undergoing Percutaneous Biliary Drainage

BackgroundBiliary obstruction in gallbladder cancer (GBC) is associated with worse prognosis and needs drainage. In patients with biliary confluence involvement, percutaneous biliary drainage (PBD) is preferred over endoscopic drainage. However, PBD catheters are associated with higher complications compared to endoscopic drainage. PBD with self-expanding metal stents (SEMS) is desirable for palliation. However, the data in patients with unresectable GBC is lacking. Materials and methodsThis retrospective study comprised consecutive patients with proven GBC who underwent PBD-SEMS insertion between January 2021 and December 2022. Technical success, post-procedural complications, clinical success, duration of stent patency, and biliary reinterventions were recorded. Clinical follow-up data was analysed at 30 days and 180 days of SEMS insertion and mortality was recorded. ResultsOf the 416 patients with unresectable GBC, who underwent PBD, 28 (median age, 50 years; 16 females) with PBD-SEMS insertion were included. All SEMS placement procedures were technically successful. There were no immediate/ early post-procedural complications/ deaths. The procedures were clinically successful in 63.6% of the patients with hyperbilirubinemia (n=11). Biliary re-interventions were done in 6 (21.4%). The survival rate was 89.3 % (25/28) at 30 days and 50% at 180 days. The median follow-up duration was 80 days (range, 8-438 days). ConclusionPBD-SEMS has moderate clinical success and 6-months patency in almost half of the patients with metastatic GBC and must be considered for palliation.

Chemo-Free Treatment Using Anti-PD-1 Antibodies with Lenvatinib in Unresectable Gallbladder Cancer: PD-L1 May Be a Potential Biomarker for a Better Outcome.

Recently, anti-PD-1 antibodies plus lenvatinib has been administered in a series of solid tumors. Yet, the efficacy of chemo-free treatment of this combined therapy has seldom been reported in gallbladder cancer (GBC). The aim of our study was to initially evaluate the efficacy of the chemo-free treatment in unresectable GBCs. We retrospectively collected the clinical data of unresectable GBCs treated using chemo-free anti-PD-1 antibodies plus lenvatinib in our hospital from March 2019 to August 2022. The clinical responses were assessed, and PD-1 expression was evaluated. Our study enrolled 52 patients, with the median progression-free survival being 7.0 months and the median overall survival being 12.0 months. The objective response rate was 46.2% and the disease control rate was 65.4%. The expression of PD-L1 in patients with objective response was significantly higher than those with progression of disease. For patients with unresectable GBC, when not eligible for systemic chemotherapy, chemo-free treatment using anti-PD-1 antibodies with lenvatinib may become a safe and rational choice. The expression of PD-L1 in tumor tissues may be correlated to the objective response, and thus is expected to be a predictor of efficacy, and further clinical studies are certainly needed.

Response Rates and Tolerance for mFOLFIRINOX Regimen in Indian Patients with Metastatic and Unresectable Gall Bladder Cancer - A Prospective Observational Study (Phase II)

Response Rates and Tolerance for mFOLFIRINOX Regimen in Indian Patients with Metastatic and Unresectable Gall Bladder Cancer - A Prospective Observational Study (Phase II)

Conversion surgery following gemcitabine plus cisplatin therapy for initially unresectable gallbladder cancer with peritoneal carcinomatosis: a case report

BackgroundConversion surgery, which is defined as chemotherapy or chemoradiotherapy followed by radical surgery, may improve survival of patients with initially unresectable advanced biliary tract cancer, including gallbladder cancer. However, there are few reports on conversion surgery for advanced gallbladder cancer.Case presentationA 69-year-old woman was referred to our hospital with initially unresectable gallbladder cancer with peritoneal carcinomatosis. She underwent gemcitabine plus cisplatin therapy for 9 months. Extended cholecystectomy, resection of the extrahepatic bile duct with regional lymph node dissection, and total omentectomy were then performed as conversion surgery. The patient has survived without recurrence for 19 months postoperatively (31 months after the initial diagnosis) while continuing chemotherapy.ConclusionsThis case suggests that conversion surgery for advanced gallbladder cancer is effective and may be curative for locally advanced disease and distant metastasis such as peritoneal carcinomatosis.

Pathological complete response achieved by gemcitabine plus cisplatin therapy for initially unresectable advanced gallbladder cancer: a case report

BackgroundConversion surgery for initially unresectable gallbladder cancer is rarely performed due to the low response rate for systemic chemotherapy, and a pathological complete response is seldom achieved.Case presentationA 67-year-old woman with jaundice was referred to our hospital and diagnosed with unresectable gallbladder cancer with extra-regional lymph node metastasis after examinations. After biliary decompression, gemcitabine plus cisplatin therapy was started. The tumor marker levels markedly decreased, and imaging studies revealed a reduction in the primary tumor and metastatic lymph nodes. The primary tumor and metastatic lymph node were still shrunk at 4 years after the start of gemcitabine plus cisplatin therapy, so we decided to perform conversion surgery. Gallbladder bed resection and lymph node dissection were performed. The pathological findings of the resected specimen showed only partial fibrosis in the gallbladder wall and no malignant findings in the dissected lymph nodes, indicating a pathological complete response. As of 24 months after the operation, she is alive without recurrence.ConclusionAlthough there have been only a few reports of conversion surgery for initially unresectable gallbladder cancer, it may be worthwhile to perform chemotherapy with the potential goal of subsequent conversion surgery.

Locally advanced gallbladder cancer treated with effective chemotherapy and subsequent curative resection: a case report

BackgroundSurgical resection of gallbladder cancer with negative margins is the only potentially curative therapy. Most patients with gallbladder cancer are diagnosed in an advanced stage and, despite the availability of several chemotherapies, the prognosis remains dismal. We report a case of locally advanced gallbladder cancer that was successfully treated with effective cisplatin plus gemcitabine, followed by curative resection.Case presentationA 55-year-old Japanese female was hospitalized with right hypochondrial pain. Enhanced computed tomography revealed a 49 × 47 mm mass at the neck of the gallbladder, with suspected invasion of the liver and right hepatic artery. Endoscopic retrograde cholangiopancreatography demonstrated displacement of the upper bile duct. Intraductal ultrasonography showed irregular wall thickening and disappearance of the wall structure in bile ducts from the B4 branch to distal B2 and B3. Percutaneous transhepatic biliary biopsy revealed a poorly differentiated carcinoma. The patient was diagnosed with unresectable gallbladder cancer (T4N0M0 stage IVA). Cisplatin plus gemcitabine chemotherapy was initiated. After six courses of chemotherapy, enhanced computed tomography showed that the mass in the neck of the gallbladder had shrunk to 30 mm, Endoscopic retrograde cholangiopancreatography showed improvement of the hilar duct stenosis. A biopsy of the bile duct mucosa showed no malignant cells in the branch of the left and right hepatic ducts, the left hepatic duct, or the intrapancreatic ducts. The patient underwent conversion surgery with right and segment 4a liver resection, extrahepatic duct resection, and cholangiojejunostomy. The histopathologic diagnosis showed that the tumor cells had shrunk to 2 × 1 mm, and that R0 resection of the T2aN0M0 stage IIA tumor was successful.ConclusionAlthough conversion surgery for gallbladder cancer is rarely possible, curative resection may offer a better prognosis, and it is important to regularly pursue possibilities for surgical resection even during chemotherapy.

An investigator-initiated study of gemcitabine and capecitabine in Indian patients with unresectable or metastatic gallbladder cancer

Background: Gallbladder cancer (GBC) has a high incidence rate in the Indo-Gangetic belt and is usually presented in the unresectable advanced or metastatic stage. In this study, we evaluated the response rate and toxicities of the gemcitabine plus capecitabine (GEM-CAP)-based combination chemotherapy in unresectable or metastatic GBC patients. Subjects and Methods: This was an investigator-initiated, single-arm, prospective study conducted on unresectable or metastatic GBC patients at Jaipur, India, for 1 year. All the patients received a GEM-CAP combination chemotherapy regimen which consisted of gemcitabine 1000 mg/m2 intravenously over 30 min on days 1 and 8 and capecitabine at 800 mg/m2 orally twice a day for 14 days, administered every 21 days. The response was evaluated in terms of overall response rate (ORR), tumor control rate (TCR), and progression-free survival (PFS). Both quantitative and qualitative toxicities were assessed. Results: A total of 35 patients were enrolled, of which 3 patients were excluded due to treatment interruption. The mean age of patients was 55 (32–80) years, with the majority being female (77.14%), having an ECOG score of 1 (71.43%), and with Stage IVB disease (77.14%). The ORR was 25%, TCR was 50%, and median PFS was 4 months. Major toxicities noted were Grade I and II hematological and nonhematological toxicities, which were managed adequately. Conclusion: The combination therapy of gemcitabine and capecitabine is reasonable, feasible, and well-tolerated approach for the treatment of unresectable advanced and metastatic GBC patients, a disease that had limited treatment options.

A case of locally advanced unresectable gallbladder cancer with long-term survival after two pulmonary resections for lung metastases after conversion surgery

A case of locally advanced unresectable gallbladder cancer with long-term survival after two pulmonary resections for lung metastases after conversion surgery

Radiotherapy for locally advanced unresectable gallbladder cancer - A way forward: Comparative study of chemotherapy versus chemoradiotherapy.

For nonmetastatic locally advanced gallbladder cancer (LAGBC) which remains unresectable and nonmetastatic after chemotherapy, there is no consensus on whether to continue chemotherapy or add local radiotherapy (RT) for improving outcomes. Forty-five patients of surgically unresectable nonmetastatic LAGBC were analyzed. Twenty patients did not receive RT (no RT cohort) and received only chemotherapy, while 25 patients received RT (RT cohort) with conformal techniques along with concurrent gemcitabine-based chemotherapy. No RT and RT cohorts were compared for disease-related outcomes and toxicities. Median follow-up of the entire cohort was 11.5 months. Two-year progression-free survival (18.6% vs. 0%, P = 0.0001) and overall survival (37.3% vs. 5%, P = 0.0001) were significantly better in the RT cohort as compared to a no RT cohort. More number of patients had locoregional progression in the no RT cohort (85% vs. 32%, P = 0.0002). Radiation-induced acute and late gastrointestinal toxicity ≥ RTOG Grade 3 were seen in one and two patients, respectively. Addition of local RT to chemotherapy improves the survival outcomes and can be considered as a definite treatment modality for nonmetastatic LAGBC patients not amenable to surgery who have responded to chemotherapy.

Retrospective analysis of the efficacy of percutaneous transhepatic biliary drainage in palliation of obstructive jaundice in patients with carcinoma gall bladder: Experience from tertiary care center in Northern India

Background: Percutaneous Transhepatic Biliary Drainage (PTBD) is a minimally invasive procedure to palliate the biliary obstruction caused by unresectable malignancy. Aims and Objective: To analyze the outcome of PTBD in patients of unresectable gall bladder cancer presenting with obstructive jaundice in terms of reduction in serum bilirubin levels, symptomatic improvement, and overall survival (OS) at 4 weeks and 12 weeks following the procedure. Materials and Methods: In this retrospective study, PTBD was attempted on 30 patients diagnosed with inoperable gall bladder cancer. Various patient and procedure-related variables were analyzed and recorded both pre and post-PTBD. Outcome data on OS was collected at 4 weeks and 12 weeks. Results: Technical success was achieved in 29 (99.66%) patients. The mean fall in the serum bilirubin at the 7th post-procedural day was 41.5% after the successful PTBD. The most common complication in our study was cholangitis noted in six (21%) patients. OS at 4 weeks and 12 weeks was 79% and 41%, respectively. Conclusion: Younger age and good performance status favored better survival rate in our study.

Nafamostat mesilate, a nuclear factor kappa B inhibitor, enhances the antitumor action of radiotherapy on gallbladder cancer cells.

Nuclear factor kappa B (NF-κB) is a transcriptional factor that can be activated by radiotherapy and chemotherapy. The synthetic protease inhibitor nafamostat mesilate (NM) inhibits NF-κB activity and exerts antitumor actions in various types of cancer. In the present study, we hypothesized that NM might enhance the antitumor action of radiotherapy on gallbladder cancer (GBC) cells by inhibiting radiation-induced NF-κB activity. Thus, we investigated the correlation between radiotherapy and NF-κB activity in GBC cells. We assessed the in vitro effects of radiotherapy with or without NM on NF-κB activity, apoptosis of GBC cells (NOZ and OCUG-1), induction of apoptotic cascade, cell cycle progression, and viability of GBC cells using four treatment groups: 1) radiation (5 Gy) alone; 2) NM (80 μg/mL and 40 μg/mL, respectively) alone; 3) combination (radiation and NM); and 4) vehicle (control). The same experiments were performed in vivo using a xenograft GBC mouse model. In vitro, NM inhibited radiation-induced NF-κB activity. Combination treatment significantly attenuated cell viability and increased cell apoptosis and G2/M phase cell cycle arrest compared with those in the other groups for NOZ and OCUG-1 cells. Moreover, combination treatment upregulated the expression of apoptotic proteins compared with that after the other treatments. In vivo, NM improved the antitumor action of radiation and increased the population of Ki-67-positive cells. Overall, NM enhanced the antitumor action of radiotherapy on GBC cells by suppressing radiation-induced NF-κB activity. Thus, the combination of radiotherapy and NM may be useful for the treatment of locally advanced unresectable GBC.

Targeted therapies for gallbladder cancer: an overview of agents in preclinical and clinical development

ABSTRACT INTRODUCTION: Gallbladder cancer (GC) is a rare malignancy with a dismal prognosis. If it is diagnosed early enough, it can be cured by surgical removal. Unfortunately, only a small GC patient population can be amenable to surgery, though, with a high relapse rate. Conventional chemotherapy remains the golden standard for unresectable or metastatic GC, both in the first and second-line settings, even if leading to a fair outcome improved AREAS COVERED: In recent years, the concept of “precision medicine”, new potential molecular targets have been examined. In the present review, a general outline of the current first- and second-line chemotherapies is provided. New therapeutic possibilities are reviewed, particularly HER2, EGFR, VEGF, TKI, MEK and BRAF inhibitors, and immunotherapy. Furthermore, published clinical trials are utilized to analyze the principal drug effectiveness in GC. EXPERT OPINION: GC is characterized by vast cancer heterogeneity and individual’s efficacy to different drugs. The ongoing trials have the potentiality of reshaping the landscape of systemic treatments for GC in the very next years. Nowadays, amongst therapeutic combinations, the addition of ICIs to chemotherapy has yielded encouraging results needing confirmation. In the next future, systematic implementation of gene profiling and further explorations of combination therapies will likely change the treatment scenario.

Should patients with unresectable gallbladder cancer with hilar involvement undergo unilateral or bilateral percutaneous biliary drainage in the setting of cholangitis?

Aim of the studyThis study aimed to evaluate the outcomes of patients with unresectable gallbladder cancer (GBC) with hilar involvement and cholangitis undergoing percutaneous transhepatic biliary drainage (PTBD).Material and methodsThis retrospective study comprised consecutive patients with unresectable GBC with cholangitis who underwent PTBD. The procedures were categorized as unilateral or bilateral. Bilateral PTBD was classified as simultaneous or sequential. The mean reduction in bilirubin at two weeks was recorded. Complications and mean overall survival were also recorded.ResultsThirty-three patients (mean age 54.5 years, 12 males) were included. Thirty patients underwent unilateral drainage. Sequential drainage of the contralateral system was performed in 11 patients. Simultaneous bilateral PTBD was performed in 3 patients. PTBD was technically successful in all patients. Mean reduction in bilirubin was 41.5% in the unilateral group. The fall of bilirubin in the simultaneous bilateral PTBD group was 39%. The mean follow-up duration was 36.5 days. No major complications were encountered. At the last follow-up, 7 patients were alive. The mean overall survival was 34.6 days.ConclusionsPatients with unresectable GBC and cholangitis frequently require bilateral drainage. However, prospective studies should be performed to evaluate whether a sequential or simultaneous PTBD should be performed.

Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder.

Objective The aim of this study is to investigate the effects of gemcitabine maintenance on progression-free survival (PFS) in patients with metastatic gallbladder cancer (GBC). Materials and Methods Sixty patients with unresectable or metastatic GBC having ongoing response to treatment with initial six cycles of gemcitabine and a platinum-based doublet chemotherapy were prospectively randomized on day 21 of the 6th cycle in 1:1 fashion to receive either maintenance gemcitabine 1 g/m 2 intravenously on day 1 and day 8 of three weekly cycle or observation. Survival analysis was performed using the Kaplan–Meier method and comparisons by the log-rank test. A p -value < 0.05 was considered as statistically significant. Results Of 60 patients, a total of 56 were available for final analysis. The median PFS was 4.7 months (3.1–6.3) in gemcitabine arm and 2.6 months (2.4–2.8) in observation arm, hazard ratio (HR) 0.196 (95% confidence interval [CI]: 0.1–0.39), p < 0.001. Median overall survival in gemcitabine arm was 12.4 months (9.15–15.6) as opposed to 9.9 months (8.29–11.5) in observation arm, HR 0.76 (95% CI: 0.43–1.35), p = 0.354. The grade 3 or 4 side effects in maintenance arm were transaminitis (17.9%), thrombocytopenia (17.8%), neutropenia (14.2%), and febrile neutropenia (7.1%). Conclusions Maintenance gemcitabine therapy in unresectable/metastatic GBC patients responding to first-line gemcitabine and platinum treatment contributes to increase PFS with minimal and manageable side effects.

Genomic Landscape and Targeted Treatment of Gallbladder Cancer: Results of a First Ongoing Prospective Study.

Background Prognosis of gallbladder cancer (GBC) has not changed in the past 20 years. Comprehensive genomic profiling (CGP) carries potential to determine the actionability for multiple targets, including ERBB2 , ERBB3 , MET , ROSI , FGFR , and PIK3 . This study evaluates the role of CGP and targeted therapies. Methods This is a multicenter, prospective, single-arm study. All consecutive patients of unresectable and/or metastatic GBC of age ≥18 years were enrolled. Hybrid capture-based CGP was performed by Foundation Medicine CDx. All patients received first-line chemotherapy with gemcitabine–cisplatin regimen. Patients with ERBB2/3 amplification received trastuzumab with capecitabine or nab-paclitaxel, and patients with MET amplification were treated with crizotinib. For ERBB2/3 mutations, lapatinib plus capecitabine regimen was used. Results Fifty patients were studied with a median age of 56 years (range 26–83) and a male-to-female ratio of 1:1.6. ERBB2 and ERBB3 amplification was seen in 9 (18%) and 2 (4%) patients, respectively. Four patients with ERBB2 amplification received trastuzumab and/or lapatinib, showed partial response, and maintained response beyond 12 weeks. One patient had mixed response, whereas two patients progressed on trastuzumab and lapatinib. Three patients with ERBB3 mutations showed response to lapatinib–capecitabine. One patient with MET amplification responded to crizotinib for 4 weeks. PIK3 mutations were present in 14% of cases and were independent of ERBB aberrations. Conclusion GBC is enriched in 28% of patients with ERBB2 and ERBB3 amplifications and/or mutations. Responses are seen with lapatinib in concurrent ERBB2 mutation and amplification. ERBB3 mutation showed response to lapatinib. MET and PIK3 are new findings in GBC, which may be targeted.

Genomic architecture of gallbladder cancer: Results of a first prospective study.

e16628 Background: Rarity in western countries precluded Gallbladder cancer (GBC) from prospective research. Comprehensive Genomic profiling carries potential to determine oncogenic pathways, driver mutations and possible resistance mechanisms. This study is evaluating the role of comprehensive genomic profiling and role of targeted therapies therein. Methods: This is a single center, prospective, study conducted from Aug2018-Dec2019. All consecutive patients of unresectable and/or metastatic GBC of age ≥18 years were enrolled. Hybrid capture based comprehensive genomic profiling was performed by Foundation Medicine CDx. Microsatellite instability and PDL1 expression were studied. Results: Median age was 56 years (range:26-83) with male to female ratio of 1:1.6. NGS information was available for 50 patients. ERBB pathway was aberrated in 44% of patients. ERBB2 &amp; ERBB3 amplification was seen in 9(18%) and 2(4%) patients respectively. ERBB2 mutations were present concurrently with amplification in 3 patients. MET amplification was present in 3 (6%) PIK3CA mutations were seen in 14% of cases. PIK3CA mutations were independent of ERBB aberrations. FGFR2 mutation, FGFR2 and FGFR3 amplification was present in one patient each. NF1 and NF2 mutations were seen in three and two patients respectively. Median TMB (n = 39) was 5 mut/Mb with range of 1-14 mut/Mb. PDL1 (n = 31) of ≥ 1% was present in 32% of cases and it ranged from 1-100%. MSI (n = 39) was stable in all cases. Other somatic mutations and/or amplifications are shown in Table. Conclusions: GBC is enriched in 28% of patients with ERBB2 &amp; ERBB3 amplifications and/or mutations. FGFR2 mutation is rare in GBC. PIK3CA aberrations are common. Phase 2 trial of frontline Trastuzumab combined with chemotherapy is ongoing. [Table: see text]

Endoscopic ultrasound-guided celiac plexus neurolysis improves pain in gallbladder cancer.

In gallbladder cancer (GBC), nearly 80% of patients present with pain in the upper abdomen. Narcotic analgesics are usually effective in relieving cancer pain, but induce adverse effects. Celiac plexus neurolysis (CPN) is an effective alternative to reduce pain caused by upper abdominal cancer; however, no published data is available on endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) for pain relief in GBC. Patient with unresectable GBC with upper abdominal pain of severity ≥ 3 on visual analogue scale (VAS), not responding to non-steroidal anti-inflammatory drugs (NSAIDs) and tramadol were recruited prospectively over a 2-year period. EUS-CPN was done using the central approach in all thepatients. Pain severity was assessed using a VAS, prior to EUS-CPN and at 2, 4, and 8weeks after CPN. The technical success was achieved in 19 of 21 patients in whom the procedure was attempted. There was a significant improvement in pain severity as measured by VAS compared with the baseline at 2 and 4weeks aftertreatment (p < .001); at 8weeks, pain severity was less but was not statistically significant. At week 2, nearly 95% of patients had either complete or partial relief of pain. This response declined to 63% and 61% at 4 and 8weeks, respectively. There was a significant reduction in daily requirement of analgesics in all thepatients at 2 and 4weeks compared with baseline (p < .001); at week 8, there was no significant reduction in analgesic dose. EUS-CPN has a high technically success in mostpatients with GBC. It improved pain in about 60% to70% patients and lowered daily analgesic dose requirement for up to 4weeks. There was no procedure-related complication.

Evaluation of platelet distribution width as novel biomarker in gall bladder cancer.

INTRODUCTION:Gall bladder cancer (GBC) tends to present in advanced stages, therefore, early diagnosis of GBC is necessary. There is no ideal single tumor marker available presently for the diagnosis and prognosis of GBC. Platelet distribution width (PDW) is an early marker for activated platelets and has been used in a variety of tumors to assess prognosis. This study was designed to evaluate the utility of PDW in identifying GBC patients and its association with tumor markers, staging and resectability of GBC.MATERIALS AND METHODS:This cross sectional study was done on 100 patients of GBC and 100 age- and sex- matched healthy controls. PDW was evaluated and compared between GBC and healthy controls. Receiver-operating characteristics was plotted to determine optimal cut-off for identifying GBC patients and to determine sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of PDW. Correlation between serum tumor markers (carbohydrate antigen 19-9, carcinoembryonic antigen, and carbohydrate antigen 125) and PDW were evaluated. Association of PDW with hyperbilirubinemia, staging and resectability of GBC was also studied.RESULTS:A significantly higher PDW with a median of 18.1 was observed in GBC as compared to healthy controls with median value of 13. PDW was found to have a very high sensitivity (90%), specificity (95%), PPV (94%) and NPV (90%) in identifying GBC at cut-off of 16 with area under the curve (AUC) of 0.97. An increase of PDW was observed with increasing stage and unresectable GBC. However, it was not statistically significant. Significant positive correlation was observed between PDW and all three serum tumor markers and good positive correlation with r = 0.61 was observed with CA 19-9.CONCLUSION:PDW was associated with GBC and may be considered as a cost- effective marker in adjunct to other investigations for the diagnosis of GBC.