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• W2045588043 abstract "Background & Aims: Patients with carcinoma of the gallbladder (GBC) and obstructive jaundice are usually not amenable to curative resection. Effective palliation by biliary decompression is the goal of treatment. Endoscopic stenting (ES) and percutaneous transhepatic biliary drainage (PTBD) can provide biliary decompression. We compared unilateral PTBD and ES in patients with a hilar block caused by GBC and assessed their quality of life (QOL). Methods: Consecutive patients with GBC not suitable for curative resection with Bismuth type 2 or 3 block were randomized to either PTBD or ES with a 10F plastic stent. Technical success, successful drainage, early cholangitis, complications, procedure-related mortality, 30-day mortality, survival, and QOL before and 1 and 3 months after stenting were compared between the 2 groups. All patients were followed up until death. Results: Fifty-four patients were randomized to PTBD or ES (27 each). Successful drainage was better in the PTBD group (89% vs 41%; P < .001). Early cholangitis was significantly higher in the ES group (48% vs 11%; P = .002). Procedure-related (4% vs 8%) and 30-day mortality (4% vs 8%) and median survival were similar (60 days in both; P = .71). Although the World Health Organization–Quality of Life 1- and 3-month physical and psychological scores were better after PTBD, the difference was not significant. The European Organization for Research and Treatment of Cancer (EORTC)–Quality of Life Questionnaire 30 global health status at 3 months was significantly better after PTBD (75 vs 30.5, P = .02). The EORTC symptom scores improved in both groups, but only fatigue was significantly better after PTBD. Conclusions: PTBD provides better biliary drainage and has lower complication rates in patients with GBC and hilar block. Background & Aims: Patients with carcinoma of the gallbladder (GBC) and obstructive jaundice are usually not amenable to curative resection. Effective palliation by biliary decompression is the goal of treatment. Endoscopic stenting (ES) and percutaneous transhepatic biliary drainage (PTBD) can provide biliary decompression. We compared unilateral PTBD and ES in patients with a hilar block caused by GBC and assessed their quality of life (QOL). Methods: Consecutive patients with GBC not suitable for curative resection with Bismuth type 2 or 3 block were randomized to either PTBD or ES with a 10F plastic stent. Technical success, successful drainage, early cholangitis, complications, procedure-related mortality, 30-day mortality, survival, and QOL before and 1 and 3 months after stenting were compared between the 2 groups. All patients were followed up until death. Results: Fifty-four patients were randomized to PTBD or ES (27 each). Successful drainage was better in the PTBD group (89% vs 41%; P < .001). Early cholangitis was significantly higher in the ES group (48% vs 11%; P = .002). Procedure-related (4% vs 8%) and 30-day mortality (4% vs 8%) and median survival were similar (60 days in both; P = .71). Although the World Health Organization–Quality of Life 1- and 3-month physical and psychological scores were better after PTBD, the difference was not significant. The European Organization for Research and Treatment of Cancer (EORTC)–Quality of Life Questionnaire 30 global health status at 3 months was significantly better after PTBD (75 vs 30.5, P = .02). The EORTC symptom scores improved in both groups, but only fatigue was significantly better after PTBD. Conclusions: PTBD provides better biliary drainage and has lower complication rates in patients with GBC and hilar block. Gallbladder cancer (GBC) is one of the most common abdominal malignancies worldwide. It has a very high incidence in Chile, Japan, and India.1Diehl A.K. Epidemiology of gallbladder cancer: a synthesis of recent data.J Natl Cancer Inst. 1980; 65: 1209-1214PubMed Google Scholar, 2Batra Y. Pal S. Dutta U. et al.Gallbladder cancer in India: a dismal picture.J Gastroenterol Hepatol. 2005; 20: 309-314Crossref PubMed Scopus (82) Google Scholar In the United States the incidence of GBC is 1.2 per 100,000, with 2800 deaths per year.3Carriaga M.T. Henson D.E. Liver, gallbladder, extrahepatic bile ducts, and pancreas.Cancer. 1995; 75: 171-190Crossref PubMed Scopus (407) Google Scholar GBC is the most common cause of malignant hilar biliary obstruction. Jaundice caused by biliary obstruction is the presenting feature in 30%–60% of patients with GBC.4Kumaran V. Gulati M.S. Paul S.B. et al.The role of dual phase helical CT in assessing resectability of carcinoma of the gallbladder.Eur Radiol. 2002; 12: 1993-1999PubMed Google Scholar The usual cause of biliary obstruction is direct infiltration of the common hepatic duct by the tumor.4Kumaran V. Gulati M.S. Paul S.B. et al.The role of dual phase helical CT in assessing resectability of carcinoma of the gallbladder.Eur Radiol. 2002; 12: 1993-1999PubMed Google Scholar Most patients with GBC and obstructive jaundice are not amenable to a curative surgical resection,4Kumaran V. Gulati M.S. Paul S.B. et al.The role of dual phase helical CT in assessing resectability of carcinoma of the gallbladder.Eur Radiol. 2002; 12: 1993-1999PubMed Google Scholar, 5Bismuth H. Castaing D. Traynor O. Resection or palliation; priority of surgery in the treatment of hilar cancer.World J Surg. 1988; 12: 39-47Crossref PubMed Scopus (325) Google Scholar and hence, effective palliation is the goal of treatment. Although surgical bilioenteric bypass has been the traditional palliative approach, it is associated with substantial morbidity and mortality.5Bismuth H. Castaing D. Traynor O. Resection or palliation; priority of surgery in the treatment of hilar cancer.World J Surg. 1988; 12: 39-47Crossref PubMed Scopus (325) Google Scholar Nonoperative alternatives in the form of percutaneous and endoscopic drainage have been used to provide effective biliary drainage.6Huibregtse K. Tytgat G.N.J. Palliative treatment of jaundice by transpapillary introduction of biliary endoprosthesis.Gut. 1982; 23: 371-375Crossref PubMed Scopus (162) Google Scholar, 7Cotton P.B. Endoscopic methods for relief of malignant obstructive jaundice.World J Surg. 1984; 8: 854-861Crossref PubMed Scopus (103) Google Scholar, 8Dowsett J.F. Vaira D. Hatfield A.R. et al.Endoscopic biliary therapy using the combined percutaneous and endosopic route.Gastroenterology. 1989; 96: 1180-1186Abstract PubMed Google Scholar, 9Becker C.D. Glattli A. Maibach R. et al.Percutaneous palliation of malignant obstructive jaundice with the Wallstent endoprosthesis: follow-up and reintervention in patients with hilar and non-hilar obstruction.J Vasc Interv Radiol. 1993; 4: 597-604Abstract Full Text PDF PubMed Scopus (111) Google Scholar, 10Stoker J. Lameris J.S. van Blankenstein M. Percutaneous metallic self-expandable endoprostheses in malignant hilar biliary obstruction.Gastrointest Endosc. 1993; 39: 43-49Abstract Full Text PDF PubMed Scopus (76) Google Scholar It has been shown that even if only 30% of the liver parenchyma is drained, it provides adequate palliation to relieve the jaundice and associated pruritus.11Polydorou A.A. Cairns S.R. Dowsett J.F. et al.Palliation of proximal malignant biliary obstruction by endoscopic endoprosthesis insertion.Gut. 1991; 32: 685-689Crossref PubMed Scopus (241) Google Scholar, 12De Palma G.D. Galloro G. Sicilliano S. et al.Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized and controlled study.Gastrointest Endosc. 2001; 53: 547-553Abstract Full Text Full Text PDF PubMed Scopus (384) Google Scholar Therefore, unilateral drainage of one lobe of the liver might be sufficient to palliate the jaundice and pruritus and improve the quality of life (QOL).12De Palma G.D. Galloro G. Sicilliano S. et al.Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized and controlled study.Gastrointest Endosc. 2001; 53: 547-553Abstract Full Text Full Text PDF PubMed Scopus (384) Google Scholar, 13Sherman S. Endoscopic drainage of malignant hilar obstruction: is one biliary stent enough or should we place two?.Gastrointest Endosc. 2001; 53: 681-684Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar, 14Cheung W.H. Kortan P. Haber G.B. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage.Gastrointest Endosc. 1998; 47: 354-362Abstract Full Text Full Text PDF PubMed Scopus (377) Google Scholar, 15Mehta S. Ozden Z.S. Dhanireddy S. et al.Endoscopic single versus double (bilateral) wallstents for palliation of malignant Bismuth type III/IV hilar strictures: comparison of clinical outcomes and costs (abstract).Gastrointest Endosc. 1999; 49: AB234Google Scholar, 16De Palma Angelo P. Maria R. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study.Gastrointest Endosc. 2003; 55: 50-55Abstract Full Text Full Text PDF Scopus (187) Google Scholar A few trials have shown that endoscopic drainage is better than percutaneous drainage in patients with lower bile duct obstruction caused by pancreatic and periampullary cancers.17Shepherd H.A. Royle G. Ross A.P. et al.Endoscopic biliary endoprosthesis in the palliation of malignant obstruction of the distal common bile duct: a randomized trial.Br J Surg. 1988; 75: 1166-1168Crossref PubMed Scopus (511) Google Scholar, 18Speer A.G. Cotton P.B. Russell R.C. et al.Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice.Lancet. 1987; 2: 57-62Abstract PubMed Scopus (621) Google Scholar However, in patients with malignant hilar obstruction (Bismuth types 2 and 3), endoscopic drainage is associated with a higher incidence of cholangitis, and the success rate varies from 40%–80%.13Sherman S. Endoscopic drainage of malignant hilar obstruction: is one biliary stent enough or should we place two?.Gastrointest Endosc. 2001; 53: 681-684Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar, 14Cheung W.H. Kortan P. Haber G.B. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage.Gastrointest Endosc. 1998; 47: 354-362Abstract Full Text Full Text PDF PubMed Scopus (377) Google Scholar On the other hand, percutaneous drainage might be associated with complications such as biliary leak and bleeding. There is no published randomized controlled trial comparing endoscopic and percutaneous drainage in patients with only malignant hilar obstruction. Hence, we did a randomized prospective trial comparing percutaneous and endoscopic biliary drainage in patients with hilar biliary obstruction caused by GBC in terms of successful drainage and QOL after the drainage. Consecutive patients with obstructive jaundice caused by GBC presenting to the outpatient departments of Gastrointestinal Surgery and Gastroenterology at the All India Institute of Medical Sciences were evaluated. The diagnosis of obstructive jaundice was established on the basis of liver chemistry (increased serum bilirubin and alkaline phosphatase levels) and an abdominal ultrasonography (US) showing dilated intrahepatic radicles. The diagnosis of GBC was made if a mass was seen arising from the gallbladder on a dual phase, contrast-enhanced computed tomography scan (CECT) of the abdomen.4Kumaran V. Gulati M.S. Paul S.B. et al.The role of dual phase helical CT in assessing resectability of carcinoma of the gallbladder.Eur Radiol. 2002; 12: 1993-1999PubMed Google Scholar Histologic and/or cytologic confirmation of malignancy was done whenever possible by a fine-needle aspiration cytology/trucut biopsy. The site of biliary obstruction was classified according to the Bismuth-Corlette classification on the basis of the preprocedural investigations that included US, CECT, and magnetic resonance cholangiopancreatography.19Schag C.C. Heinrich R.L. Ganz P.A. Karnofsky performance status revisited: reliability, validity, and guidelines.J Clin Oncol. 1984; 2: 187-193Crossref PubMed Scopus (1123) Google Scholar The final differentiation between types 2 and 3 blocks was based on the findings noted during the biliary intervention, ie, endoscopic or percutaneous. Patients with GBC and hilar block (Bismuth type 2 or 3 block) not suitable for curative resection with 1 or more of the following criteria were included: (1) jaundice with serum bilirubin >10 mg/dL, (2) pruritus, and (3) cholangitis. Patients with 1 or more of the following were excluded from the study: (1) patients with resectable cancer as judged on imaging studies, (2) patients with a poor performance status: Karnofsky index <60,20Jarnagin W.R. Burke E. Powers C. et al.Intrahepatic biliary enteric bypass provides effective palliation in selected patients with malignant obstruction at the hepatic duct confluence.Am J Surg. 1998; 175: 453-460Abstract Full Text Full Text PDF PubMed Scopus (101) Google Scholar (3) Bismuth type 1 or 4 block, (4) uncontrolled ascites, (5) duodenal obstruction, and (6) patients who opted for insertion of a metal stent. The number of patients to be included in each group was calculated to be 91 on the basis of the assumption that percutaneous drainage would be better than endoscopic drainage by 20% in terms of successful drainage. The sample size was calculated for a power of 80% and alpha error of 0.05. However, we could enroll 54 patients during the stipulated study period of 2 years. The reason for lesser numbers was exclusion of patients as a result of the predetermined exclusion criteria. However, the power of the study was 96% on reverse calculation for intention-to-treat analysis. The trial is registered at www.ClinicalTrials.gov (NCT00409864) and was approved by the institutional ethics committee, and patients were included after informed consent. The random numbers were computer-generated. The patients were randomized by using the sealed envelope technique into 2 groups: group A, percutaneous transhepatic biliary drainage (PTBD) and group B, endoscopic stenting (ES). The baseline investigations obtained included hemoglobin, blood cell counts, blood urea, serum creatinine, serum electrolytes, blood sugar, liver chemistry, and prothrombin time.21Gulati M.S. Srinivasan A. Agarwal P.P. Percutaneous management of malignant biliary obstruction: the Indian perspective.Trop Gastroenterol. 2003; 24: 47-58PubMed Google Scholar A chest x-ray and an electrocardiogram were also obtained. All patients received injectable prophylactic antibiotic (cefoperazone + sulbactam 1 g) for 72 hours starting 2 hours before the procedure. Patients were kept nil by mouth for 8 hours before the procedure and were well-hydrated with intravenous fluids. The procedure was performed under conscious sedation (midazolam and pentazocine). Either a right- or left-sided approach was used for PTBD. Patients with extensive right-sided disease and/or right lobe atrophy with sparing of the left lobe were subjected to a left-sided approach and vice-versa. For type 2 blocks either the right anterior or left system was chosen (left was chosen if the left lobe of the liver was not atrophied). For type 3a blocks (right secondary confluence involved), a left-sided drainage was done, whereas for type 3b blocks, a right-sided drainage was done. An anterior subxiphoid approach was used for the left duct, whereas a right lateral approach was used for the right duct. The procedure was done under ultrasound guidance, and the skin entry was through the intercostal space below the costophrenic angle. Once entry was gained to a suitable duct, the standard Seldinger technique was used to place a guidewire in the biliary system. The tract was dilated, and after crossing the obstruction with a hydrophilic guidewire (Terumo; Terumo Inc, Tokyo, Japan), a ring biliary 8F catheter (Cook Medical, Bloomington, IN) was placed to provide internal-external drainage. In a subsequent session (done 1–2 days later), a 10F straight plastic stent (polyurethane) was placed in the biliary system through a sheath across the obstruction to provide internal drainage. A standard 8F pigtail drainage catheter was placed just proximal to the stent to maintain access to the ductal system for 1–2 days after internalization. This was done to facilitate flushing of the system to prevent clogging of the stent and to facilitate further intervention, if the stent should block or migrate. A cholangiogram study was done through the external drainage catheter to ensure good stent function, and then it was removed, leaving the tract to heal. Endoscopic retrograde cholangiography was performed with a therapeutic duodenoscope (TJF 160; Olympus, Tokyo, Japan), and a standard sphincterotome was used for cannulation of the bile duct. A hydrophilic guidewire (Terumo, 0.032-inch diameter; Terumo Inc, or Jag wire 0.035-inch diameter; Boston Scientific Microvasive, Natick, MA) was used to cross the malignant stricture. After crossing the stricture, bile was aspirated, and then a limited cholangiogram was done. A small-size sphincterotomy was done to facilitate the passage of the stent. A 10F straight plastic stent was inserted across the stricture. If a patient had a failed insertion of the stent by either procedure, he or she was considered for the other technique. These patients were included in the crossover group for per protocol analysis. The primary outcome measures were successful drainage and QOL. Successful drainage was defined as reduction in bilirubin to <50% of the pretreatment value within 7 days after drainage. The secondary outcome measures included early and late complications, procedure-related mortality, 30-day mortality, stent patency time, and survival. The early and late complications were defined as those occurring within 30 days and after 30 days of stent placement, respectively. Early cholangitis was defined as cholangitis occurring during the first 7 days after the procedure as evidenced by fever, leukocytosis with worsening biochemical parameters. A procedure-related mortality was defined as death directly related to complications of the procedure. The duration of stent patency was defined as the period of time from stent insertion to stent occlusion. The stent was considered to be occluded when patients had abnormal/worsening biochemical parameters and/or cholangitis. It was confirmed by biliary dilatation in the drained lobe on US. The World Health Organization (WHO)–QOL BREF-26 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-30) scores were used to assess the QOL. WHO-QOL BREF-2623World Health Organization handbook for reporting results of cancer treatment World Health Organization publication no. 48. World Health Organization, Geneva1979Google Scholar has 26 items, which cover physical, psychological, social, and environmental domains. WHO-QOL domain scores were calculated by using the guidelines given in the WHO-QOL scoring manual. A high score represented a high level of QOL. The EORTC QLQ-3024Aaronson N.K. Ahmedzai S. Bergman B. et al.The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.J Natl Cancer Inst. 1993; 85: 365-376Crossref PubMed Scopus (11221) Google Scholar consists of 30 generally applicable items. The time taken to administer the questionnaire was between 30 and 75 minutes. A high score for a functional scale represented a high/healthy level of functioning, a high score for global health status/QOL represented high QOL, but a high score for symptom scale/item represented a higher level of symptomatology/problem. Clinical, hematologic, and biochemical parameters were reassessed at days 2, 7, and 30 after stent placement and every 3 months thereafter. QOL was assessed before procedure and 1 and 3 months after the procedure. All patients were instructed to contact the hospital if any symptom suggestive of a complication appeared. Additional information regarding current status or death was obtained directly from the referring physician or from the patient during outpatient visit or by telephone/letter. Data were analyzed by both intention-to-treat and per protocol methods. The per protocol analysis was done for patients with a successful stent placement including crossover with either ES or PTBD approach. The baseline characteristics are expressed as mean (standard deviation). Pearson χ2 test or Fisher exact test was used for comparison of categorical data. The unpaired Student t test was used for comparison of continuous variables between the groups. Survival was expressed in months as median (range). Cumulative survival was estimated by using Kaplan-Meier life table analysis, and the groups were compared by log-rank χ2 test. The QOL score analysis was done with paired t test for comparison of scores at different intervals. Multivariate analysis of variance was used to assess the trend of the scores. For multiple comparisons, Bonferroni correction was applied. A P value <.05 was considered significant. The data were analyzed with the SPSS version 12.0 software (SPSS Inc, Chicago, IL). Between October 2003 and July 2005, 127 patients with GBC and obstructive jaundice were evaluated. Seventy-three patients were excluded as a result of various causes (Table 1). Fifty-four patients fulfilled the inclusion criteria as shown in Figure 1.Table 1Reasons for Exclusion of Patients From the Study (n = 73)IndicationNo. of patientsSurgical resection7Duodenal obstruction5Ascites11Bismuth type 1 block11Bismuth type 4 block1Common bile duct stone3Karnofsky index <606Stented previously3Metastasis1Metallic stenting1Bilirubin <10 g/dL and no pruritus5Refused procedure25 Open table in a new tab The baseline characteristics were similar in both groups (Table 2). The histologic diagnosis could be established in 54% of cases, whereas in the others the diagnosis was based on the clinical and radiologic findings. Twenty-four patients (44%) presented with cholangitis. According to the Bismuth-Corlette classification, 24 patients (44%) had a type 2 hilar block, and 30 (56%) had a type 3 hilar block. Of the 30 patients with type 3 block, 17 were in the PTBD group and 13 in the ES group. Of these 17 patients in the PTBD group, 15 (88%) had left-sided drainage, and 2 (12%) had right-sided drainage. Of the 13 patients in the ES group, 6 (46%) had left-sided drainage, 6 (46%) had right-sided drainage, and in 1 patient the stricture could not be crossed.Table 2Baseline Characteristics of the PatientsCharacteristicPTBD (n = 27)ES (n = 27)P valueAge (y)51.3 ± 1250 ± 13.70Sex (M/F)10/178/19.76Hemoglobin (g/dL)11.2 ± 210.9 ± 1.5.55Total leukocyte count (×103)/cm11 ± 312 ± 4.9.36Bilirubin (g/dL)20 ± 6.421.6 ± 6.5.37Alkaline phosphatase (IU/L)794 ± 514803 ± 548.94Aspartate transferase (IU)117 ± 61152 ± 87.09Alanine transferase (IU)78 ± 37115 ± 107.09Histologic diagnosis15 (55%)14 (51%)1.00Cholangitis11 (41%)13 (48%).78Gallstones14 (51%)11 (41%).58Type of stricture Bismuth type 210 (37%)14 (51%).41 Bismuth type 317 (63%)13 (49%) Open table in a new tab The successful stent insertion rate was higher in the PTBD group (93%) compared with the ES group (82%), but the difference was not significant (Table 3). Of the 5 patients in the ES group who were technical failures, 2 underwent PTBD as a salvage procedure, whereas 3 refused further treatment. The stricture could not be crossed in 1 patient in the PTBD group, and the patient was kept on external drainage. All failures were due to inability to pass a guidewire across the stricture. Two patients in each group required more than 1 attempt to cross the stricture.Table 3Comparison Between PTBD and ES According to Intention-to-Treat AnalysisOutcomePTBD (n = 27)ES (n = 27)P valueTechnical success26 (93)22 (81).19Successful drainage24 (89)11 (41)<.001Early complications5 (18)14 (52).04Early cholangitis3 (11)13 (48).002Procedure-related mortality1 (4)2 (8)1.0030-day mortality1 (4)2 (8).61Stent occlusion8 (32)9 (39).63Median survival, days (range)60 (43–77)60 (28–92).71NOTE. Values in parentheses are percentages except where indicated. Open table in a new tab NOTE. Values in parentheses are percentages except where indicated. Successful drainage was significantly more in the PTBD group than in the ES group (89% vs 41%, P ≤ .001). The early complication rate was significantly more in the ES group (52% vs 18%, P = .04); early cholangitis was the most common complication in the ES group (48% vs 11%, P = .002). Other complications in the ES group included mild acute pancreatitis (1), ooze from the sphincterotomy site (1), and stent migration (1). All these were managed conservatively. In the PTBD group, 3 patients had stent migration and were managed successfully with a second stent insertion. Two patients with a migrated stent developed bile leak. They were successfully managed with reinsertion of the stent. The causes of early cholangitis in the ES group were stent blockage (6), stent migration (1), unsuccessful stent insertion (1), and incomplete drainage with ongoing cholangitis (5). All the patients with cholangitis were admitted to hospital and were treated with intravenous fluid and injectable antibiotics. Three patients underwent PTBD as a salvage procedure. Stents were replaced in 4 patients with a blocked stent and in 1 patient with a migrated stent. Two patients were kept on endoscopic nasobiliary drainage, and the remaining 3 patients were treated with antibiotics alone. All 3 patients who developed cholangitis in the PTBD group had opacification of the contralateral biliary system. These ducts were drained with balloon dilatation of the stricture at the time of the initial procedure without placement of a second stent. Two of these patients could be managed with antibiotics alone, whereas 1 patient required another stent placement in the contralateral system. The procedure-related mortality did not differ between the 2 groups (4% vs 8%, P = 1.00). All deaths were a result of cholangitis. The 30-day mortality was not significantly different between the 2 groups and was again related to cholangitis (Table 3). Late complications were related to stent occlusion or progressive disease. The mean stent patency time (standard deviation) was 140 (54) days in the PTBD group and 90 (61) days in the ES group. During follow-up, 6 patients developed gastric outlet obstruction, 4 in the PTBD group and 2 in the ES group. All the patients were followed up until death. The median survival time was similar in the PTBD and ES groups [60 days (43–77) vs 60 days (28–92); P = .71]. The Kaplan-Meier survival curve is shown in Figure 2. Successful drainage was significantly higher in the PTBD group (92% vs 50%, P = .001). The early complication and cholangitis rates were significantly less in the PTBD group (Table 4). The procedure-related mortality, 30-day mortality, and stent occlusion rate and patency were similar in the 2 groups. The median survival time was not significantly different.Table 4Comparison Between PTBD and ES According to Per Protocol AnalysisOutcomePTBD (n = 28)ES (n = 22)P valueSuccessful drainage26 (92)11 (50).001Early complications5 (18)13 (59).01Early cholangitis3 (10)12 (54).001Procedure-related mortality1 (3)2 (9).5730-day mortality1 (4)2 (10).57Stent occlusion8 (30)9 (50).24Median survival, days (range)53 (37–68)75 (35–114).49NOTE. Values in parentheses are percentages except where indicated. Open table in a new tab NOTE. Values in parentheses are percentages except where indicated. The QOL questionnaires were scored according to per protocol analysis. Questionnaires of all patients except 2 patients in the PTBD group and 4 patients in the ES group, who had died within 30 days, were available at the time of first follow-up at 1 month after stenting. Only 9 patients survived for 3 months in each group. The questionnaires of all these patients were available for analysis. At baseline, WHO-QOL BREF-26 scores in all domains except psychological were similar in both groups (Table 5; see supplemental material online at www.cghjournal.org). Within the group, scores before and after stenting did not show any significant difference at 1 month but showed a significant improvement in the physical domain (P = .02) at 3 months after stenting in the PTBD group. The comparison of scores before and after stenting in the ES group showed no significant improvement at 1 month but showed higher scores in all 4 domains at 3 months. However, the difference was statistically significant only in the environmental domain of QOL. Intergroup comparison of scores in all domains showed higher physical and psychological functioning scores in the PTBD group at 1 month after stenting. At 3 months, it again showed higher physical and psychological functioning scores in the PTBD group but lower social and environmental scores compared with the ES group. However, these differences were not statistically significant. The trend analysis showed improvement in all domains at 3 months of follow-up in both groups. The difference was statistically significant only in the environmental domain in the ES group (Table 6; see supplemental material online at www.cghjournal.org). The comparison of EORTC QLQ-30 scores before and at 1 month after stenting in the PTBD group showed statistically significant improvement in cognitive functioning score (P = .04). At 3 months, the global health status was better in the PTBD group, but this difference was no" @default.
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• W2045588043 title "Endoscopic or Percutaneous Biliary Drainage for Gallbladder Cancer: A Randomized Trial and Quality of Life Assessment" @default.
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• W2045588043 doi "https://doi.org/10.1016/j.cgh.2008.03.028" @default.
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