Abstract
Abstract
Malignant bowel obstruction (MBO) frequently defines the trajectory of end-stage ovarian cancer and results in severe physical and psychological distress in patients and their caregivers. Venting gastrostomy (VG) is an alternative to both prolonged medical therapy with nasogastric intubation and intestinal bypass/diversion for refractory MBO. Limited published data from large academic research centers support use of VG in patients with advanced ovarian cancer and MBO. In this case series, we describe supportive care outcomes in ovarian cancer patients with MBO receiving the effects of VG in a community setting. Six cases of advanced ovarian cancer involving MBO were evaluated for VG from July 2009 through February 2012. Five of six patients were managed with VG. Our experience suggests that VG may be beneficial in controlling nausea and vomiting in ovarian cancer patients with MBO and that VG placement with concurrent evacuation of large-volume ascites was associated with minimal complications. Future prospective studies to evaluate the benefits of VG are warranted.
Introduction
M
Reports of successful use of venting gastrostomy (VG) for management of MBO have appeared in the literature for over a century.7,8 Recent gynecologic oncology and multidisciplinary studies provide preliminary data on the safety and efficacy of VG in supportive care of ovarian cancer patients treated at major cancer research institutions.9–17 However, the feasibility of VG placement in community hospitals, applicability of VG in routine community home hospice, and home health supportive care, and preliminary efficacy of VG decompression on improved performance status and control of enteric symptoms otherwise requiring hospitalization or inpatient hospice care remain unassessed.
In this case series, we describe supportive care outcomes in ovarian cancer patients with MBO receiving the effects of VG in a community setting. We also compare these results with previously published studies on VG and identify areas meriting further investigation regarding VG in similar patients.
Methods
Institutional Review Board approval was obtained for retrospective chart review of the initial seven consecutive ovarian cancer patients with MBO symptoms evaluated for VG candidacy after admission to the Gynecologic Oncology/Palliative Care services at St. Mary's Medical Center, Huntington, West Virginia, from July 2009 through February 2012. These seven patients underwent computed tomography (CT) scans confirming locations of tumor recurrence and gastrointestinal obstruction. One patient was excluded after CT scan confirmed that bowel obstruction resulted from incarcerated hernias instead of recurrent malignancy. Six patients underwent VG attempts for MBO. Five of six patients successfully completed VG placement and were followed by one author as primary home hospice (4) or home health (1) physician upon hospital discharge. These cases are individually reviewed. We based our literature review on recent systematic reviews, supplemented by targeted searches of MEDLINE.
Results
Patient 1
Ms. A was a 60-year-old woman who underwent primary cytoreduction to minimal residual disease for Stage IVA grade 2 ovarian carcinoma prior to 12 cycles of carboplatin/taxol chemotherapy with complete platinum response. She relapsed with MBO symptoms at 36 months after fourth-line chemotherapy. Intermittent paracentesis and later indwelling suction catheter drainage of ascites improved symptoms; subsequent drainage of persistent lesser sac ascites with a second suction catheter for clinical gastric outlet obstruction did not relieve progressive MBO symptoms. A nasogastric tube was placed without pharmacological management. Eight weeks after initial symptoms, a large-bore VG (#21) was placed by endoscopy without complication. Her nausea and vomiting improved from 8/10 pre-VG to 1/10 post-VG by Edmonton Symptom Assessment System (ESAS) scoring. 18 She tolerated clear liquids without recurrent symptoms and was discharged within 3 days with VG and both bulb suction catheters for ascites to home hospice care. Use of a small VG gravity drainage bag without suction facilitated ambulation outside her bedroom, permitting relaxed visitation with spouse, neighbors, and her four long-term rescue dogs. She expired on home hospice continuous care 2 weeks after VG placement in continued enteric symptom control.
Patient 2
Ms. B was a 68-year-old woman with clinical Stage IIIC grade 3 ovarian carcinoma with poor prognostic factors for primary cytoreduction, including large-volume ascites and CA-125 greater than 2500. She received four cycles of neoadjuvant carboplatin/taxol chemotherapy with clinical complete response and CA-125 under 100. She underwent interval cytoreduction to minimal residual disease, but recurred 4 months later on continued chemotherapy. She progressed on second-line chemotherapy with recurrent ascites, and developed MBO 12 months after initial diagnosis. Therapeutic paracentesis of ascites without catheter drainage and medical management of nasogastric tube, dexamethasone, and octreotide did not reverse MBO symptoms. Laparotomy to exclude postoperative surgically correctable obstruction revealed MBO with extensive carcinomatosis and adhesions precluding bypass or diversion. An open large-bore VG (#24) was placed. Her nausea and vomiting improved from 8/10 pre-VG to 2/10 post-VG by ESAS scoring. She tolerated sips of water, clear liquids, and some thinned full liquids postoperatively. She was discharged to home hospice care 7 days postoperative open VG placement. Although readmission was required 2 weeks later for unrelated management of urosepsis and dyspnea with pleural effusions, her nausea and vomiting remained at initial post-VG levels of 2/10 requiring occasional haloperidol and ondansetron. She remained lucid and calm, and was able to engage with both spiritual care and her family to discuss further interventions, which she declined. Ms. B remained on the palliative care service for terminal dyspnea management, expiring 4 weeks after open VG in good enteric symptom control and interacting with spouse and children until the last 48 hours of life.
Patient 3
Ms. C was an 80-year-old patient with clinical stage IVA grade 3 ovarian carcinoma. Symptoms included positive pleural effusion, ascites, and omental biopsy with CA-125 greater than 1000. Significant cardiovascular and renal disease conferred high-risk surgical status. She declined antineoplastic therapy for ovarian cancer. However, she strongly requested symptom management that would allow her to return home and, if possible, die on her farm. She was admitted to home hospice care. Pleural effusions were managed by outpatient thoracenteses and ascites by tunneled peritoneal catheter after repeat paracenteses. Symptoms of MBO occurred at 3 months refractory to medical therapy with nasogastric intubation and dexamethasone. A small-bore VG (#14) was placed by radiological technique under CT guidance and conscious sedation without complications. She was discharged back to home hospice care 2 days postprocedure. Nausea and vomiting symptoms improved from 8/10 pre- to 2/10 post-VG by ESAS scoring. She tolerated sips of clear liquids and small bites of pureed and soft foods, including a piece of birthday cake for her 81st birthday with her family. She expired 4 weeks after VG placement in good enteric symptom control, with home hospice continuous care for the last 72 hours to support home death.
Patient 4
Ms. D was a 37-year-old patient with Stage IIIC grade 2 ovarian carcinoma who underwent cytoreductive surgery to minimal residual disease followed by six cycles of carboplatin/taxol chemotherapy with complete platinum response. She received two lines of chemotherapy before experiencing MBO symptoms 48 months post initial diagnosis. MBO proved reversible twice with medical management, rotation of chemotherapy, and limited pelvic radiotherapy and vaginal brachytherapy. One episode of suspect MBO was relieved after documentation of clinical cholecystitis/cholelithiasis by laparoscopic cholecystectomy with laparoscopically confirmed unobstructed distal small intestine. She received four lines of chemotherapy before relapsing with refractory MBO 66 months after diagnosis. After failure of medical therapy of nasogastric intubation, dexamethasone, and octreotide for obstruction involving the distal one-half of small intestine radiographically, she underwent small-bore VG (#14) placement by radiological technique under CT guidance. Nausea and vomiting improved from 8/10 pre-VG to 1/10 post-VG by ESAS scoring. She was discharged to home hospice care 4 days after VG placement. She tolerated clear liquids and thin slurries initially and small portions of normal foods later. She was able to accompany her pre-teen and adolescent daughters to local festivals and school events in her small town with intermittent VG clamping. Eight weeks after VG, with advocacy by her home hospice nurse, we discussed topotecan for continued antineoplastic management. However, the patient elected continued home hospice care to maximize her time with family and arrange for care of her daughters after her death. She survived 16 weeks post-VG without chemotherapy or total parenteral nutrition (TPN), declining over the last 2 weeks and expiring in good enteric symptom control on home hospice continuous care.
Patient 5
Ms. E is a 62-year-old patient with Stage IIIC grade 2 ovarian carcinoma who underwent cytoreductive surgery to minimal residual disease followed by 12 cycles of carboplatinum/taxol chemotherapy with complete platinum response. She developed initial MBO 36 months after diagnosis with relapse after second-line chemotherapy and pelvic radiotherapy. She was treated successfully for 18 months by medical management with episodic nasogastric decompression of reversible MBO and rotation through fourth-line chemotherapy before developing refractory MBO in the distal one-half of the small intestine.
After failure of medical therapy of nasogastric intubation, dexamethasone, and octreotide, a large-bore (#26) VG was placed by endoscopy without complication. Nausea and vomiting improved from 8/10 pre-VG to 2/10 post-VG by ESAS scoring. She was discharged 2 days later to home health agency care. She was placed on TPN at 2 weeks and fifth-line chemotherapy at 4 weeks using cis-platinum and bevicuzamib. Her MBO again resolved with complete clinical response and normal CA-125. Chemotherapy and TPN were discontinued. VG was maintained to assure sustained response. Five months after VG and complete response, symptoms of MBO recurred. Ms. E wished to resume antineoplastic therapy and was restarted on cyclic TPN and sixth-line topotecan chemotherapy. She again experienced complete response confirmed by clinical examination, CT scan, and normal CA-125. Topotecan was discontinued after three cycles owing to bone marrow tolerance. She continued to travel outdoors for periods of 1 to 2 hours by motorized scooter around her small farm with intermittent VG clamping. The VG continued to relieve symptoms at a level of 2/10 or less by ESAS scoring with gastrointestinal tolerance limited to clear liquids and small amounts of solids for approximately 12 months, with normal exam, imaging, and CA-125. Three supportive care admissions were required for venous catheter exchange and antibiotics or treatment of fluid or electrolyte disorders accompanying nausea and vomiting occasioned by exuberant dietary intake, although not accompanied by blocking of the VG at any time.
After 12 months, restaging including CA-125s and positron emission tomography (PET)/CT scans remained an no evidence of disease (NED). She underwent laparotomy with no evidence of active disease and ileoascending enterocolostomy, accompanied by cholecystectomy for documented cholecystitis/cholelithiasis. She resumed regular diet and the VG was removed 8 weeks postoperatively. She remains NED by clinical examination and normal CA-125 80 months postdiagnosis, 26 months post-VG placement and 6 months post-bowel bypass and VG removal. Her palliative performance status has remained between 80 and 90 postoperatively.
Patient 6
Ms. F was a 65-year-old patient with Stage IIIC grade 2 ovarian carcinoma who underwent cytoreduction surgery including total omentectomy and full resection of the gastrocolic ligament to under 1 cm disease followed by three cycles intravenous/three cycles intravenous/intraperitoneal chemotherapy with complete response on clinical trial. She developed MBO throughout the entire small intestine 50 months postdiagnosis on fourth-line hormonal clinical trial. CT scan demonstrated cephalad gastric displacement and splenic disease on CT at presentation with MBO. Medical management with nasogastric intubation, dexamethasone, and octreotide was unsuccessful after 7 days. An Initial attempt at VG placement by interventional radiology using CT was unsuccessful owing to gastric fixation above the costal margin and tumor encasement of the stomach. A second attempt at VG by interventional radiology with continuous ultrasound and concomitant endoscopic approach under general anesthesia to maximize gastric distention failed owing to limited gastric expansivity and failure of transillumination. In lieu of VG placement, immediate nasoduodenal intubation and subsequent percutaneous tube cecostomy under conscious sedation were performed to relieve progressive borborygmus and megacolon. Terminal inpatient palliative care was initiated with death in good symptom control 72 hours later.
Table 1 summarizes patient characteristics including age, clinical or surgical stage (International Federation of Gynaecology and Obstetrics; FIGO), tumor grade, prior lines of chemotherapy and maximal response to first-line chemotherapy, presence or absence of ascites at decision for VG, method of venting gastrostomy tube placement and caliber of tube placed, interval from diagnosis to MBO, interval from initial MBO to VG placement, and interval from VG placement to death. Histology was serous ovarian carcinoma in all patients.
FIGO Staging of Ovarian Cancer as per the Manual International Federation of Gynaecologists and Obstetricians, 2009; tumor grade 2=moderately differentiated, grade 3=poorly differentiated/undifferentiated.
Surgical status: optimal cytoreduction to intraperitoneal/retroperitoneal disease tumor residual ≤1.0 cm implants.
Chemotherapy response: CR=complete clinical response; PR=partial clinical response.
Method of placement: EGD=upper GI endoscopy with percutaneous tube insertion; IR=radiographically guided percutaneous tube insertion by imaging technique; SURG=laparotomy with open gastrostomy tube placement.
Caliber of VG tube: F=French.
EGD, endoscopy; IR, interventional radiology; MBO, malignant bowel obstruction; NED, no evidence of disease (104 weeks since VG); SURG, surgery; VG, venting gastrostomy tube.
Pre-VG management of ascites was by indwelling suction catheter placement in two patients and pretreatment therapeutic paracentesis before open surgical exploration and open VG in one patient. None of the three patients with ascites experienced VG placement difficulty or related postprocedure complications.
As shown in Table 1, VG approaches used included two endoscopic (EGD), two radiological (IR), and one open surgical placement at laparotomy (SURG). Patient 6 had attempts by both interventional radiological and simultaneous interventional radiological and endoscopic access for placement of VG tube that were unsuccessful owing to multifactorial displacement of a nonexpandable stomach above the left costal margin. A nasoduodenal tube was successfully placed endoscopically under anesthesia with radiological guidance for alternative palliative decompression in this circumstance.
Table 2 summarizes patient outcomes. In this initial study, we assessed enteric symptom control of nausea and vomiting, which informed the decision for VG placement by determining ESAS nausea and vomiting score pre-VG and post-VG, determined the interval from nasogastric tube placement to VG placement (days), and evaluated the pharmacological therapy implemented before VG placement. We also assessed Palliative Performance Scale (PPS) pre-VG and post-VG as a parameter supportive of sustained transition to home hospice or home health care. Discharges in this series occurred in under 4 days in both EGD and IR placements and in expected 7 days for surgical gastrostomy at laparotomy with the nasogastric tube removed within 24 hours in all five VG placements. We assessed discharge venue for all patients, whether readmission was required, and if readmitted whether this related to VG complications or unrelated symptom management.
DC, discharge status, noting all patients went home with VG to gravity (four home hospice, one home health); DXM, dexamethasone 4 mg to 12 mg intravenous daily; ESAS, Edmonton Symptom Assessment System 18 (0=none to 10=worst imaginable by patient report scoring); HAL, haloperidol 1 mg or 2 mg intravenous every 6 hours as needed; MBO, malignant bowel obstruction; OCT: octeotide 100 mcg subcutaneous every 8 hours around the clock (intravenous or monthly octreotide not used in this study); OND, ondanestron 4 mg or 8 mg intravenous or oral disintegrating tablet every 6 hours as needed; PPS, Palliative Performance Scale 19 (0=death to 100=full normal); Readmit, reason for readmission noting that no patient was admitted with complications of VG or failure of VG to adequately control MBO symptoms; TPN, total parenteral nutrition; VG, venting gastrostomy.
No patients in this series experienced major or minor complications related to VG placement or function. Two patients (4 and 5) with Stage IIIC grade 2 ovarian cancer without ascites had survivals in excess of 60 days (112 and 728+days) and attained PPS compatible with consideration of palliative antineoplastic therapy with VG. Patient 5 resumed chemotherapy (sixth line) with resolution of MBO and remains in disease remission 728+days post-VG. Survivals post-VG in four hospice patients exceeded those appropriate for general inpatient hospice care (14 to 112 days postdischarge) and facilitated sustained home hospice care for our patients. Patients 1, 3, and 4 on home hospice care, all desirous of remaining at home at end of life and residing in excess of one hour from hospital/inpatient hospice facilities, received terminal care under the Medicare Hospice Continuous Care benefit in their remote locations and avoided transport for general inpatient care by the use of VG.
No hospice patient (4 of 5 patients) received TPN as inconsistent with hospice goals of care and National Hospice and Palliative Care Organization (NHO) guidelines for the Medicare/Medicaid Hospice medical benefit. Patient 5 with survival greater than 728 days and on home health did receive TPN as well as palliative chemotherapy per her goals with prolonged response to date.
ESAS scoring of nausea and vomiting and PPS scoring of performance status were used to assess VG impact before versus after placement only during hospital admission.18–19
Table 3 summarizes the current literature available regarding VG and symptoms.
Includes ovarian, fallopian tube, endometrial, primary peritoneal when stated; excludes cervical and uterine sarcoma histology.
Number of total cases in which VG was successfully placed on one or more attempts.
Presence of any ascites regardless of volume or evacuation/method if undertaken.
Relief of nausea and vomiting to equivalent of ESAS 2/10 or less or ECOG Grade 0 or 1 where described (five studies).
Oral intake regardless of liquid or solid consistency or volume (eight studies).
Patients discharged to home, skilled nursing facility, or hospice general inpatient care facility (seven studies).
All complications from minor (e.g., tube occlusion/revision/exchange) to major (e.g., sepsis, peritonitis, intraperitoneal leak, death) included when described (eight studies).
Survival in days from placement of VG to death.
ECOG, Eastern Cooperative Oncology Group; ESAS, Edmonton Symptom Assessment System.
Discussion
Interventional procedures including VG provide an important option in palliation in advanced cancer with MBO. In this case series, we report that VG was associated with improvement of intensity of nausea, oral intake, and may have facilitated patients' stay in home hospice. No procedure-related deaths or major complications occurred post-VG in our series.
In this case series nausea improved with VG placement. Previous studies of similar patients also report significant improvement of nausea11,13,14,16 and quality of life post-VG.4,12,20 Additionally, all five patients in this series with PPS of 20 to 40 before VG experienced stable to improved levels of PPS after VG (Table 2).
All patients successfully completing VG in our series resumed modified oral intake, and no patient experienced intake-related tube malfunction. Nine previous studies report experience in 251/433 (58%) patients with VG placement successfully resuming oral intake.9,11–17,21 Rath et al. observed that patients who tolerate a regular diet have a statistically significant survival advantage (220 versus 35 days, p<0.007 ) accompanying VG interventions. 16 Tolerance of regular feedings in their study may relate to use of percutaneous endoscopic gastrostomy (PEG) large bore tubes, which are less prone to clogging by succus or ingested foods. Nonetheless, 9 of their 15 patients required rehospitalization for management of VG obstruction subsequently resolved by dietary restrictions. They concluded that VG patients should generally observe liquid diets to avoid mechanical VG tube obstruction, consistent with our experience. Additionally, in five studies assessing nausea and vomiting, 227 of 249 patients (91.2%) had improvement equivalent to an ESAS score of 0–2 or an Eastern Cooperative Oncology Group (ECOG) grade 0 or 1 toxicity with VG (Table 3).9,11,13,14,16.In eight studies assessing oral intake of any nature, 345 of 494 patients (77.7%) reported some type of oral intake with VG.9,11–17,21
With appropriate dietary modification, VG may contribute to overall psychosocial comfort and support anticipatory grief work, permitting oral sustenance particularly crucial to specific cultures and faith systems. Future studies should prospectively address this important question. Four patients were discharged to sustained home hospice care with control of gastrointestinal symptoms by VG (Table 1) without readmission for visceral symptoms or VG complications. Previous studies reflect similar outcomes in 216 of 414 patients (52%) undergoing VG who were discharged into a home or skilled nursing unit environment, commonly without readmission, in a supportive care or home hospice setting.9,11,12,14–17
Large-bore tubes of greater than 20 French (20F) were used in two PEG and one open VG. One patient maintained the same large-bore VG tube for over 21 months without infection or obstruction. Smaller tubes of 14F were placed with T-fastener support in two CT-guided radiological procedures. All five patients experienced adequate symptom relief regardless of method of VG placement or caliber of VG tube. As our study parameters included nausea/vomiting and PPS before and after VG placement and success of sustained home hospice or home health dispositions through use of VG, we determined the endpoint was feasibility of VG tube placement and implications of posthospital VG use regardless of technique. In the literature, 809 of 830 patients (97.1%) reported on over 20 years had VG placement with either PEG by endoscopy or PDGT by image-directed interventional radiology approaches, with fewer experiences with open surgical gastrostomy (69) or PDGJT (40) interventions.9,11–17,20–24,26 All methods achieved desired symptom control objectives with no overt selection advantages for any technique other than institutional preference or resources. Data for tube size was recorded in 13 studies of VG placement. In 611 of 806 VG attempts (75.8%) reported a large-bore VG (20F or above) was used in 280 patients and small-bore VG (under 20F) in 311 patients.9,11–17,20–24,26 Large-bore tubes were placed by endoscopic or open method and small-bore in PDGT interventional radiological procedures reflecting common device availability for each method. As open gastrostomy was infrequently reported in our reference base, review confirmed only that the symptom control and complication rate appeared similar to other methods. Further studies regarding technique and tube size impacting overall quality of life improvement are needed.
No procedure-related deaths or major complications occurred post-VG in our series. One reason may be continuity as described above with close supervision of intake. A combined complication rate of 14.3% (67/467) in patients was reported in 11 series reviewed.9,11,12–17,21,22,24,25 Only four deaths among 467 patients were directly attributed to VG insertion.21,22,25 Cautious monitoring for VG complications and inclusion of imaging confirmation to restore patency and affirm proper tube position are imperative even for patients on palliative/hospice care to avoid rehospitalization or additional symptom burden, as noted by Mori et al. 27
As medical management with dexamethasone with or without octreotide was effective in up to 50% of reported cases, pharmacological therapy and short-term nasogastric tube decompression remain appropriate before considering VG placement.5,28 One algorithm for VG implementation has been proposed by Shaw et al., although this study does not include evidence-based data from their institution that informs this reasonable rationale. 15 However, in case where VG is contraindicated due to left upper quadrant gastric fixation from tumor encasement and/or surgical adhesions or anterior bowel fixation, there are limited studies to show which alternatives (e.g., medication versus nasogastric tube) would be more effective in improving quality of life. Also there are limited studies regarding whether there would be a decrease in medication use post-VG.
Prompt implementation of VG for initial or recurrent MBO symptoms in ovarian cancer patients has the advantages of lessening protracted symptom burden, reducing the number of readmissions for sporadic medical/nasogastric tube interventions, and facilitating sustained discharges to a home or home hospice setting for those patients whose goals of care and disease status favor discontinuation of antineoplastic therapy. Further controlled studies using symptom assessment scales and evaluation of performance status from oncologic or palliative performance assessments before and after VG placement appear justified by our experience and review of available single-institution evidence-based studies referenced.
Conclusions
Our experience from these six patient case reports suggests that VG was beneficial in controlling nausea and vomiting, and concurrent evacuation of large-volume ascites was associated with minimal complications in ovarian cancer patients with MBO. VG also facilitates efficient hospital discharge to sustained home hospice or home health settings, and, in selected patients, VG may permit continued palliative antineoplastic treatment of recurrent ovarian malignancy. Future prospective studies to evaluate the benefits of VG are warranted.
Author Disclosure Statement
No competing financial interests exist.
