Katja Schlosser1, Detlef K Bartsch, Markus K Diener, Christoph M Seiler, Tom Bruckner, Christoph Nies, Moritz Meyer, Jens Neudecker, Peter E Goretzki, Gabriel Glockzin, Ralf Konopke, Matthias Rothmund. 1. *Department for General, Visceral, and Vascular Surgery, Agaplesion Evangelisches Krankenhaus Mittelhessen, Giessen, Germany †Department for Visceral, Thoracic, and Vascular Surgery, University Hospital of Giessen and Marburg, Marburg, Germany ‡Department for General, Visceral, and Transplantation Surgery, University Heidelberg, Heidelberg, Germany §Institute of Medical Biometry and Informatics, University Heidelberg, Heidelberg, Germany ¶Department for General and Visceral Surgery, Marienhospital Osnabrück, Osnabrück, Germany ||Department for General, Visceral, Vascular, and Thoracic Surgery, Universitätsmedizin Berlin, Charité Campus Mitte, Berlin, Germany **Department of Surgery, Lukaskrankenhaus Neuss, Neuss, Germany ††Department of Surgery, University Medical Center Regensburg, Regensburg, Germany ‡‡Department of Visceral, Thoracic, and Vascular Surgery, Carl Gustav Carus University Hospital, Dresden, Germany.
Abstract
OBJECTIVE: This randomized controlled multicenter pilot trial was conducted to find robust estimates for the rates of recurrence of 2 surgical strategies for secondary hyperparathyroidism (SHPT) within 36 months of follow-up. BACKGROUND:SHPT is a frequent consequence of chronic renal failure. Total parathyroidectomy with autotransplantation (TPTX+AT) and subtotal parathyroidectomy (SPTX) are the standard surgical procedures. Total parathyroidectomy alone (TPTX) might be a good alternative, as morbidity and recurrence rates are low according to small-scale retrospective studies. METHODS: The trial was performed as a nonconfirmatory randomized controlled pilot trial with 100 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 3-year follow-up period afterTPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 3-year follow-up. RESULTS: A total of 52 patients underwentTPTX and 48 TPTX+AT. Patient characteristics, preoperative baseline data, duration of surgery (02:29 vs 02:47 hrs, P = 0.17) and mean hospital stay (10 ± 7.1 vs 8 ± 3.7 days, P = 0.11) did not differ significantly. Persistent SHPT developed in 1 TPTX and 2 TPTX+AT patients. None of the TPTX patients required delayed parathyroid AT to treat permanent hypoparathyroidism. Serum-calcium values were similar (2.1 ± 0.3 vs 2.1 ± 0.2, P = 0.95) whereas PTH rose by time in the TPTX+AT group and was significantly higher at the end of follow-up when compared with the TPTX group (31.7 ± 43.6 vs 98.2 ± 156.8, P = 0.02). Recurrent SHPT developed in 4 TPTX+AT and none of the TPTX patients. CONCLUSIONS:TPTX+AT and TPTX seem to be safe and equally effective for the treatment of otherwise uncontrollable SHPT. TPTX seems to suppress PTH more effectively and showed no recurrences after 3 years. The hypothesis that TPTX is superior to TPTX+AT referring to the rate of recurrent SHPT has to be tested in a large-scale confirmatory trial. Nevertheless, TPTX seems to be a feasible alternative therapeutic option for the surgical treatment of SHPT.
RCT Entities:
OBJECTIVE: This randomized controlled multicenter pilot trial was conducted to find robust estimates for the rates of recurrence of 2 surgical strategies for secondary hyperparathyroidism (SHPT) within 36 months of follow-up. BACKGROUND: SHPT is a frequent consequence of chronic renal failure. Total parathyroidectomy with autotransplantation (TPTX+AT) and subtotal parathyroidectomy (SPTX) are the standard surgical procedures. Total parathyroidectomy alone (TPTX) might be a good alternative, as morbidity and recurrence rates are low according to small-scale retrospective studies. METHODS: The trial was performed as a nonconfirmatory randomized controlled pilot trial with 100 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 3-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 3-year follow-up. RESULTS: A total of 52 patients underwent TPTX and 48 TPTX+AT. Patient characteristics, preoperative baseline data, duration of surgery (02:29 vs 02:47 hrs, P = 0.17) and mean hospital stay (10 ± 7.1 vs 8 ± 3.7 days, P = 0.11) did not differ significantly. Persistent SHPT developed in 1 TPTX and 2 TPTX+ATpatients. None of the TPTXpatients required delayed parathyroid AT to treat permanent hypoparathyroidism. Serum-calcium values were similar (2.1 ± 0.3 vs 2.1 ± 0.2, P = 0.95) whereas PTH rose by time in the TPTX+AT group and was significantly higher at the end of follow-up when compared with the TPTX group (31.7 ± 43.6 vs 98.2 ± 156.8, P = 0.02). Recurrent SHPT developed in 4 TPTX+AT and none of the TPTXpatients. CONCLUSIONS:TPTX+AT and TPTX seem to be safe and equally effective for the treatment of otherwise uncontrollable SHPT. TPTX seems to suppress PTH more effectively and showed no recurrences after 3 years. The hypothesis that TPTX is superior to TPTX+AT referring to the rate of recurrent SHPT has to be tested in a large-scale confirmatory trial. Nevertheless, TPTX seems to be a feasible alternative therapeutic option for the surgical treatment of SHPT.
Authors: T Weber; C Dotzenrath; H Dralle; B Niederle; P Riss; K Holzer; J Kußmann; A Trupka; T Negele; R Kaderli; E Karakas; F Weber; N Rayes; A Zielke; M Hermann; C Wicke; R Ladurner; C Vorländer; J Waldmann; O Heizmann; S Wächter; S Schopf; W Timmermann; D K Bartsch; R Schmidmaier; M Luster; K W Schmid; M Ketteler; C Dierks; P Schabram; T Steinmüller; K Lorenz Journal: Langenbecks Arch Surg Date: 2021-04-21 Impact factor: 3.445
Authors: Thomas Burgstaller; Andreas Selberherr; Lindsay Brammen; Christian Scheuba; Klaus Kaczirek; Philipp Riss Journal: Langenbecks Arch Surg Date: 2018-12-05 Impact factor: 3.445