A randomized, controlled trial of the efficacy of percutaneous transesophageal gastro-tubing (PTEG) as palliative care for patients with malignant bowel obstruction: the JIVROSG0805 trial

Abstract

Background

A randomized, controlled trial to evaluate the superiority of percutaneous transesophageal gastro-tubing over nasogastric tubing as palliative care for bowel obstruction in patients with terminal malignancy was conducted.

Subjects and methods

The subjects were patients with malignant bowel obstruction with no prospect of improvement, for whom surgery was not indicated and with a Palliative Prognostic Index of < 6. They were randomly allocated in a 1:1 ratio to receive either percutaneous transesophageal gastro-tubing (PTEG group) or nasogastric tubing (NGT group). Their symptom scores (the worst 0 to no symptoms 10) were measured for a 2-week period after enrollment, and the areas under the curves for the two groups were compared. The EQ-5D and SF-8 were also used to assess overall quality of life.

Results

Forty patients were enrolled between October 2009 and January 2015, with 21 allocated to the PTEG group and 19 to the NGT group. The mean areas under the curves (95% confidence intervals) for the PTEG group and the NGT groups were 149.6 (120.3–178.8) and 44.9 (16.4–73.5), respectively, significantly higher for the NGT group (p < 0.0001). The secondary endpoints of quality of life as assessed by the EQ-5D and SF-8 scores were also significantly higher for patients in the PTEG group (p = 0.0036, p = 0.0020). There was no difference in survival between the groups. No serious adverse events were observed.

Conclusions

In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2

References

  1. 1.

    Tsuneto S, Ikenaga M, Hosoi J, Kashiwagi T (1998) Malignant intestinal obstruction. In: Eguchi K (ed) Current perspective and future directions palliative medicine. Tokyo, Springer, pp 25–32

  2. 2.

    Maeno H (2001) Octreotide for gastrointestinal symptoms of terminal cancer patients [in Japanese]. Terminal Care 11:181–185

    Google Scholar 

  3. 3.

    Ripamonti C (1994) Management of bowel obstruction in advanced cancer. Curr Opin Oncol 6:351–357

    CAS  Article  Google Scholar 

  4. 4.

    Davis MP, Nouneh C (2000) Modern management of cancer-related intestinal obstruction. Curr Oncol Rep 2:343–350

    CAS  Article  Google Scholar 

  5. 5.

    Mercadante S, Casuccio A, Mangione S (2007) Medical treatment for inoperable malignant bowel obstruction: a qualitative systematic review. J Pain Symptom Manag 33:217–223

    CAS  Article  Google Scholar 

  6. 6.

    Cullen J (2001) Percutaneous endoscopic gastrostomy. Oper Tech Gen Surg 3:263–268

    Article  Google Scholar 

  7. 7.

    Pearl ML, Valea FA, Fischer M, Chalas E (1996) A randomized controlled trial of postoperative nasogastric tube decompression in gynecologic oncology patients undergoing intra-abdominal surgery. Obstet Gynecol 88:399–402

    CAS  Article  Google Scholar 

  8. 8.

    Ponsky JL, Gauderer MWL (1981) Percutaneous endoscopic gastrostomy: a nonoperative technique for feeding gastrostomy. Gastrointest Endosc 27:9–11

    CAS  Article  Google Scholar 

  9. 9.

    Gauderer MWL, Ponsky JL, Izant RJ Jr (1980) Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg 15:872–875

    CAS  Article  Google Scholar 

  10. 10.

    Pothuri B, Montemarano M, Gerardi M, Shike M, Ben-porat L, Sabbatini P, Barakat RR (2005) Percutaneous endoscopic gastrostomy tube placement in patients with malignant bowel obstruction due to ovarian carcinoma. Gynecol Oncol 96:330–334

    Article  Google Scholar 

  11. 11.

    Maple J, Petersen B, Baron T, Gostout C, Song L, Buttar N (2005) Direct percutaneous endoscopic jejunostomy: outcomes in 307 consecutive attempts. Am J Gastroenterol 100:2681–2688

    Article  Google Scholar 

  12. 12.

    Ripamonti CI, Easson AM, Gerdes H (2008) Management of malignant bowel obstruction. Eur J Cancer 44:1105–1115

    Article  Google Scholar 

  13. 13.

    Kawata N, Kakushima N, Tanaka M, Sawai H, Imai K, Hagiwara T, Takao T, Hotta K, Yamaguchi Y, Takizawa K, Matsubayashi H, Ono H (2014) Percutaneous endoscopic gastrostomy for decompression of malignant bowel obstruction. Dig Endosc 26:208–213

    Article  Google Scholar 

  14. 14.

    Mercadante S, Spoldi E, Caraceni A, Maddaloni S, Simonetti MT (1993) Octreotide in relieving gastrointestinal symptoms due to bowel obstruction. Palliat Med 7:295–299

    CAS  Article  Google Scholar 

  15. 15.

    Khoo D, Hall E, Motson R, Riley J, Denman K, Waxman J (1994) Palliation of malignant intestinal obstruction using octreotide. Eur J Cancer 30A:28–30

    CAS  Article  Google Scholar 

  16. 16.

    Cascinu S, Del Ferro E, Catalano G (1995) A randomized trial of octreotide vs best supportive care only in advanced gastrointestinal cancer patients refractory to chemotherapy. Br J Cancer 71:97–101

    CAS  Article  Google Scholar 

  17. 17.

    Mangili G, Franchi M, Mariani A, Zanaboni F, Rabaiotti E, Frigerio L, Bolis PF, Ferrari A (1996) Octreotide in the management of bowel obstruction in terminal ovarian cancer. Gynecol Oncol 1:345–348

    Article  Google Scholar 

  18. 18.

    Maeno H, Ikenaga M, Tsuneto S, Kashiwagi T (1996) The effect of octreotide for bowel obstruction in terminally cancer patients. Jpn J Clin Res Death Dying 19:49–52

    Google Scholar 

  19. 19.

    Shima Y, Ohtsu A, Shirao K, Sasaki Y (2008) Clinical efficacy and safety of octreotide (SMS201-995) in terminally ill Japanese cancer patients with malignant bowel obstruction. Jpn J Clin Oncol 38:354–359

    Article  Google Scholar 

  20. 20.

    Oishi H, Murata J, Kameoka S (1998) Percutaneous transesophageal gastric tube drainage. Development and perspective of rupture-free balloon catheter for puncture [in Japanese]. J Jpn Surg Soc 99:275

    CAS  Google Scholar 

  21. 21.

    Chen AS (1983) Method and means for esophageal feeding. United States Patent. Washington, D.C. 4384584

  22. 22.

    Nakano Y, Kitabayashi K, Sawa T (1993) Two cases of nutrition tube placement by cervical esophagostomy: esophageal dilatation method. J Jpn Surg Soc:943–945

  23. 23.

    Udomsawaengsup S, Brethauer S, Kroh M, Chand B (2008) Percutaneous transesophageal gastrostomy (PTEG): a safe and effective technique for gastrointestinal decompression in malignant obstruction and massive ascites. Surg Endosc 22:2314–2318

    CAS  Article  Google Scholar 

  24. 24.

    Oishi H, Shindo H, Shirotani N, Kameoka S (2001) Percutaneous transesophageal gastrotubing (PTEG): development and practice [in Japanese]. Jpn J Intervent Radiol 16:149–155

    Google Scholar 

  25. 25.

    Oishi H, Shindo H, Shirotani N, Kameoka S (2003) A nonsurgical technique to create an esophagostomy for difficult cases of percutaneous endoscopic gastrostomy. Surg Endosc 17:1224–1227

    CAS  Article  Google Scholar 

  26. 26.

    Mackey R, Chand B, Oishi H, Kameoka S, Ponsky JL (2005) Percutaneous transesophageal gastrostomy tube for decompression of malignant obstruction: report of the first case and our series in the US. J Am Coll Surg 201:695–700

    Article  Google Scholar 

  27. 27.

    Aramaki T, Arai Y, Inaba Y, Sato Y, Saito H, Sone M, Takeuchi Y (2013) Phase II study of percutaneous transesophageal gastrotubing for patients with malignant gastrointestinal obstruction; JIVROSG-0205. J Vasc Interv Radiol 24:1011–1017

    Article  Google Scholar 

  28. 28.

    Takeuchi Y, Arai Y, Sone M, Sugawara S, Aramaki T, Sato R, Kichikawa K, Tanaka T, Morishita H, Ito T, Yamakado K, Baba Y, Kobayashi T (2019) Evaluation of stent placement for vena cava syndrome: phase II trial and phase III randomized controlled trial. Support Care Cancer 27:1081–1088

    Article  Google Scholar 

  29. 29.

    Tsuchiya A, Ikeda S, Ikegami N, Nishimura S, Sakai I, Fukuda T, Hamashima C, Hisashige A, Tamura M (2002) Estimating an EQ-5D population value set: the case of Japan. Health Econ 11:341–353

    Article  Google Scholar 

  30. 30.

    Fukuhara S, Suzukamo Y (2004) Manual of the SF-8 Japanese version. Institute for Health Outcomes & Process Evaluation Research

Download references

Acknowledgments

The authors are grateful to their patients and the staff of all participating institutions.

Funding

Funding from the Japan Agency for Medical Research and Development (AMED) [16ck0106058h0003 to Y.A.], the Ministry of Health, Labour and Welfare of Japan [H26-055 to Y.A.], and the National Cancer Center Research and Development Fund [26-A-27 to M.S.] is gratefully acknowledged.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Takeshi Aramaki.

Ethics declarations

Conflict of interest

Y.A. Speaker’s Bureau from Guerbet Japan, Kyorin Pharma, Canon Medical Systems and Fuji Pharma, Royalty from Sumitomo Bakelite, and Advisor fee from Japan Lifeline.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Aramaki, T., Arai, Y., Takeuchi, Y. et al. A randomized, controlled trial of the efficacy of percutaneous transesophageal gastro-tubing (PTEG) as palliative care for patients with malignant bowel obstruction: the JIVROSG0805 trial. Support Care Cancer 28, 2563–2569 (2020). https://doi.org/10.1007/s00520-019-05066-8

Download citation

Keywords

  • Percutaneous transesophageal gastro-tubing
  • Malignant bowel obstruction
  • Palliative medicine
  • Quality of life
  • Randomized controlled trial