Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial


Robert S. Krouse, University of Pennsylvania, Philadelphia, PA
Garnet L. Anderson, Fred Hutchinson Cancer Center, Seattle, WA
Kathryn B. Arnold, Fred Hutchinson Cancer Center, Seattle, WA
Cynthia A. Thomson, University of Arizona, Tucson, AZ
Valentine N. Nfonsam, LSU Health Sciences Center - New OrleansFollow
Mazin F. Al-Kasspooles, University of Kansas Cancer Center, Kansas City, KS
Joan L. Walker, University of Oklahoma, Oklahoma City, OK
Virginia Sun, City of Hope National Medical Center, Duarte, CA
Angeles Alvarez Secord, Duke Cancer Institute, Durham, NC
Ernest S. Han, City of Hope National Medical Center, Duarte, CA
Alberto M. Leon-Takahashi, National Cancer Institute, Tlalpan, Mexico City
David Isla-Ortiz, National Cancer Institute, Tlalpan, Mexico City
Phillip Rodgers, University of Michigan, Ann Arbor, MI
Samantha Hendren, University of Michigan, Ann Arbor, MI
Marco Sanchez Salcedo, Instituto Nacional de Enfermedades Neoplásicas, Surquillo, Peru
Jonathan A. Laryea, University of Arkansas for Medical Sciences, Little Rock, AR
Whitney S. Graybill, Medical University of South Carolina, Charleston, SC
Devin C. Flaherty, Valley Health, Winchester, VA
Harveshp Mogal, Medical College of Wisconsin, Milwaukee, WI
Thomas J. Miner, Rhode Island Hospital, Providence, RI
Jose M. Pimiento, H Lee Moffitt Cancer Center, Tampa, FL
Mio Kitano, University of Texas Health San Antonio, San Antonio, TX
Brian Badgwell, MD Anderson Cancer Center, Houston, TX
Giles Whalen, Umass Memorial Medical Center, Worcester, MA
Jeffrey P. Lamont, Baylor University Medical Center, Dallas, TX
Oscar A. Guevara, Instituto Nacional de Cancerologia, Bogota, Colombia
Maheswari S. Senthil, Loma Linda University Health, Loma Linda, CA
Summer B. Dewdney, Rush University Medical Center, Chicago, IL
Eric Silberfein, Baylor College of Medicine, Houston, TX
et al

Document Type


Publication Date


Publication Title

The Lancet Gastroenterology and Hepatology


Background: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. Methods: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0–2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with, NCT02270450. Findings: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI –5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3–4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). Interpretation: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. Funding: Agency for Healthcare Research and Quality and the National Cancer Institute. Translation: For the Spanish translation of the abstract see Supplementary Materials section.

First Page


Last Page


PubMed ID







See article for full author list.